On May 15, 2020 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended March 31, 2020 (Press release, Soligenix, MAY 15, 2020, View Source [SID1234558190]).

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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "This has been a very rewarding year for us thus far. Our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial continues to demonstrate SGX301’s potential to be an important new treatment for early-stage cutaneous T-cell lymphoma (CTCL). In the double-blind, placebo controlled Cycle 1 portion of the study, a statistically significant treatment response (p=0.04) was achieved in the primary endpoint after 6 weeks of therapy. This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycle, referred to as Cycle 2, with an additional 6 weeks of therapy (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment). We also continue to advance our pivotal Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy. Following the positive recommendation received from the independent Data Monitoring Committee, we have successfully achieved our target of 260 patients randomized into the study; however, due to the uncertainty surrounding the coronavirus pandemic, we decided to enroll up to 25 additional patients into the study. We are taking this cautious approach in order to maintain the statistical integrity of the trial, by accounting for patients that may potentially drop out of the study before completing their protocol required study treatment and evaluations. Therefore, the study target to complete enrollment and provide top-line results has been revised to the fourth quarter 2020; however, this will continue to remain dependent on the medical and logistical challenges caused by the coronavirus showing a reasonable level of improvement in the relative near-term."

Dr. Schaber continued, "Under our Public Health Solutions business segment, we continue to advance our work with University of Hawaiʻi at Mānoa (UH Mānoa) on filovirus vaccines (protecting against viruses such as Ebola and Marburg) and the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19. We continue to support our heat stable ricin vaccine, RiVax, with a National Institute of Allergy and Infectious Disease contract award of $21.2 million. With over $8M in cash, not including our non-dilutive government funding, along with the at-the-market sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including top-line results in our SGX942 Phase 3 clinical trial in oral mucositis."

Soligenix Recent Accomplishments

On May 11, 2020, the Company announced publication of immunogenicity studies for RiVax identifying novel correlates of immune protection to facilitate potential approval under the United States Food and Drug Administration (FDA) "Animal Rule." The article, titled "A Multivariate Model Combining Endpoint and Epitope-specific Antibody Responses as a Correlate of Protection to Ricin Toxin," has been submitted to the peer-reviewed medical journal Vaccine and a preprint is available here. To view this press release, please click here.
On May 7, 2020, the Company announced that it had received approximately $840,000, net of transaction costs, in non-dilutive financing via the State of New Jersey’s Technology Business Tax Certificate Transfer Program. To view this press release, please click here.
On April 30, 2020, the Company announced that continued treatment with SGX301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40% (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment) in Cycle 2 of its pivotal Phase 3 FLASH study for the treatment of early-stage CTCL. These highly statistically significant results confirm the benefit of continued SGX301 treatment in CTCL patients. To view this press release, please click here.
On April 16, 2020, the Company announced it had executed an agreement for the exclusive worldwide license of CoVaccine HT, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation (NYSE: BSX), for the fields of pandemic flu and coronaviruses, including SARS-CoV-2, the cause of COVID-19. To view this press release, please click here. This collaboration further builds on the recently announced collaboration between the UH Mānoa and Soligenix to develop a SARS-CoV-2 vaccine (available here).
On April 6, 2020, the Company announced that the European patent office has granted the divisional patent application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 2932973). The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of CTCL. To view this press release, please click here.
Financial Results – Quarter Ended March 31, 2020

Soligenix’s revenues for the quarter ended March 31, 2020 were $0.9 million as compared to $1.1 million for the quarter ended March 31, 2019. Revenues included payments on a contract in support of RiVax, our ricin toxin vaccine candidate, grants received to support the development of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases, ThermoVax, our thermostabilization technology, and the assessment of SGX942 safety in juvenile animals.

Soligenix’s basic net loss was $7.6 million, or ($0.32) per share, for the quarter ended March 31, 2020, as compared to $1.6 million, or ($0.09) per share, for the quarter ended March 31, 2019. This increase in net loss was primarily the result of the issuance of $5 million of common stock as a milestone payment triggered by the successful Phase 3 clinical trial of SGX301 for the treatment of CTCL and increased research and development spending. The number of shares of common stock issued as a milestone payment was calculated using an effective price of $2.56 per share, based upon a formula set forth in the applicable agreement.

Research and development expenses were $2.7 million as compared to $1.6 million for the quarters ended March 31, 2020 and 2019, respectively. The increase in research and development spending for the quarter ended March 31, 2020 was primarily attributable to the site and patient fees for the pivotal Phase 3 clinical trials of SGX301 and SGX942, compared to the same period in 2019.

General and administrative expenses were $0.9 million for both the three months ended March 31, 2020 and 2019.

As of March 31, 2020, the Company’s cash position was approximately $7.2 million, not including the approximate $840,000 recently received from the State of New Jersey’s Technology Business Tax Certificate Transfer Program.

On May 15, 2020 ESSA Pharma Inc. (Nasdaq: EPIX; TSX-V: EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported new preclinical data on ESSA’s clinical candidate, EPI-7386, at the 2020 Virtual American Urological Association ("AUA") Annual Meeting (Press release, ESSA, MAY 15, 2020, View Source [SID1234558189]).

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In an oral poster presentation titled, "The preclinical characterization and development of EPI-7386, an N-terminal domain androgen receptor inhibitor for the treatment of prostate cancer", a more in-depth preclinical characterization of EPI-7386 including gene expression analyses and the toxicologic profile was presented. The studies highlight new information about EPI-7386 including:

In vitro cellular gene expression analyses demonstrate that EPI-7386:
Inhibits androgen-induced genes with major similarities but some differences from enzalutamide in a cellular model sensitive to androgen receptor inhibitors.
In the same cellular model, the combination of enzalutamide and EPI-7386 inhibits androgen-induced gene expression more completely and broadly.
EPI-7386 shows superiority to enzalutamide in inhibiting androgen-induced genes in an androgen receptor resistant model, and in contrast to enzalutamide, also blocks genes induced by the AR-V7 androgen receptor splice variant.
Toxicology studies evaluating the safety profile of EPI-7386 demonstrate that:
Very high plasma exposures of EPI-7386 were achieved across all studies.
The drug was well tolerated at both the low and middle doses, corresponding to drug plasma exposures 2-5 fold higher than the efficacious exposures achieved in mouse xenograft models.
The highest doses tested were characterized as the HNSTD (highest non-severely toxic dose) and only exhibited body weight loss and reduced food consumption. The drug plasma exposures achieved at this high dose were 7-10 fold higher than the efficacious exposures achieved in mouse xenograft models.
The starting clinical dose of EPI-7386 will be 200 mg given once-daily
"The breadth of in vitro and in vivo studies utilized to profile EPI-7386 preclinically demonstrate an encouraging profile for EPI-7386 across a variety of antiandrogen sensitive and antiandrogen-resistant cellular models, xenograft and patient-derived xenograft mouse models, and gene expression analyses. The favorable toxicologic profile of EPI-7386 observed in our IND-enabling studies at very high exposures will permit initiation of the Phase 1 study at a dose of 200 mg per day, which should allow us to reach biologically relevant blood levels of EPI-7386 in patients quickly," said Dr. David R. Parkinson, President & Chief Executive Officer. "We look forward to beginning patient dosing soon in our initial phase 1 study of EPI-7386 in mCRPC patients whose tumors are progressing on current anti-androgens.".

On May 15, 2020 Seneca Biopharma, Inc. (Nasdaq: SNCA), a biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, reported its financial results for the quarter ended March 31, 2020 (Press release, Seneca Biopharma, MAY 15, 2020, View Source [SID1234558188]).

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Business Highlights for 2020 to date.

During the First Quarter of 2020, the Company achieved the following business milestones:

Continued progress on the Company’s out-licensing effort to partner NSI-566 and NSI-189 programs, while seeking to in-license or acquire novel therapeutics that could benefit from its development experience.
Completion of an inducement offering resulting in net proceeds of $6.7 million.
Appointed of Matthew W. Kalnik, Ph.D. as President and Chief Operating Officer and Dane R. Saglio as Chief Financial Officer.
Affirmed guidance that data readout from the Company’s non-GCP Phase II trial evaluating NSI-566, for the treatment of chronic ischemic stroke, is expected during the second half of 2020.
Announced that as a result of feedback received from the FDA, Seneca believes that the existing Phase 1 and 2 trial results support moving into a Phase 3 clinical study for ALS.
Completion of the Company’s stem cell manufacturing facility in Suzhou, China which will be used to manufacture NSI-566 for clinical trials within China.
Financial Results for the Quarter Ended March 31, 2020

Cash Position and Liquidity: At March 31, 2020, cash was approximately $10 million as compared to approximately $5.1 million at December 31, 2019. The increase in cash is attributed to the January 2020 warrant inducement transaction.

Operating Loss: Operating loss for the quarter ended March 31, 2020 was $2.0 million compared to a loss of $2.5 million for the comparable 2019 period. The decrease in operating loss for 2020 was primarily due to a decrease in R&D expenses as we continue to wind down the clinical programs. This decrease was partially offset by an increase in G&A expenses which reflects an enhanced management structure to support corporate objectives as compared to the same period of 2019.

Net Loss: Net loss for the period ended March 31, 2020 was $7.6 million, or $0.93 per share, compared to a loss of $3.1 million, or $3.42 per share on a post-reverse stock-split basis, for the same period in 2019. The change in net loss was primarily attributed to a non-cash expense of $5.6 million related to the January 2020 warrant inducement transaction.

"With Matt and Dane joining the management team we are focused on executing on the strategy of acquiring new therapeutic products for development while seeking partners for our promising neural stem cell therapeutic NSI-566," commented Dr. Kenneth Carter, Seneca’s Executive Chairman.

On May 15, 2020 GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, reported acceptance of three presentations on pre-clinical data for its proprietary universal CAR-T platform (UniCAR) targeting acute leukemia and solid tumors at the 2020 Virtual Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR II) being held from June 22-24 (Press release, GEMoaB, MAY 15, 2020, View Source [SID1234558187]).

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CAR-T cell therapy holds great promise for treating a wide range of malignancies. Nevertheless, the CAR-T approach faces multiple challenges, including the risk of acute and long-term toxicities, a current lack of suitable targets, insufficient engraftment and persistence and a microenvironment hostile to CAR-T cells especially in solid tumors.

The AACR (Free AACR Whitepaper) poster presentations highlight GEMoaB’s rapidly switchable universal CAR-T platform, UniCAR. The UniCAR platform promises an improved therapeutic window and increased efficacy and safety over conventional CAR-T therapies in hematological malignancies and solid tumors.

"At this year’s AACR (Free AACR Whitepaper) meeting II, we are pleased to present important pre-clinical data from our rapidly switchable UniCAR platform," said Armin Ehninger, Ph.D., Chief Scientific Officer of GEMoaB. "Our data suggest the opportunity to actively target CD123 in acute leukemias as well as PSMA and PD-L1 in solid tumors due to UniCAR’s rapid switch on/off capability. In solid tumor models, they also show potentially superior tumor penetration, expansion and persistence capabilities as well as a reduced risk of immunosuppression by the tumor microenvironment."

The data further support the ongoing clinical development of UniCAR in hematological malignancies and solid tumors. A Phase IA dose-finding study of the first UniCAR asset, UniCAR-T-CD123, for the treatment of relapsed/refractory AML and ALL is ongoing. A Phase IA study with UniCAR-T-PSMA directed against CRPC and other PSMA-expressing late-stage solid tumors will be initiated by H2 2020.

GEMoaB’s poster presentations at AACR (Free AACR Whitepaper) II:

Dietrich et al. Abstract No. 2209 / 14 – Rapidly switchable universal CAR-T cells with improved safety profile allow for active targeting of PD-L1 expressing solid tumors. – PO.IM02.06 – Combination Immunotherapies 2, June 22, 2020, 9:00 AM – 6:00 PM (EDT).
Cartellieri et al. Abstract No. 2176 / 8 – Using a PSMA-specific low-molecular-weight compound for prostate cancer treatment with rapidly switchable universal CAR-T cells: Overcoming the challenges of cellular immunotherapies in solid tumors. – PO.IM02.02 – Adoptive Cell Therapy 2, June 22, 2020, 9:00 AM – 6:00 PM (EDT).
Loff et al. Abstract No. 4232 / 6 – More than a bridging therapy: Targeting CD123 with rapidly switchable universal CAR-T cells for treatment of acute leukemia. – PO.CL06.02 – Adoptive Cell Therapy 4 / Combination Immunotherapies, June 22, 2020, 9:00 AM – 6:00 PM (EDT).

On May 15, 2020 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company") reported financial results for the first quarter ended March 31, 2020 and provided an update on its business (Press release, Titan Pharmaceuticals, MAY 15, 2020, View Source [SID1234558186]).

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First Quarter 2020 Highlights

In January 2020, Titan completed an offering resulting in net cash proceeds of approximately $1.9 million.
Since January 1, 2020, the Company received proceeds of approximately $6.7 million as a result of the exercise of previously issued common stock purchase warrants.
COVID-19 Impact and Adjusted Probuphine Commercial Strategy

Titan’s commercial operations expansion has continued throughout the past several months, with additions to its sales and medical liaison teams, including support from additional marketing and medical access staff, that now provide coverage for all 50 states and Puerto Rico. Unfortunately, the emergence of the COVID-19 pandemic during the latter half of the first quarter and the resulting restrictions on travel and social distancing rules that have minimized personal physician/patient interaction, except in emergencies, has hindered the effectiveness of the commercial team. In order to try and mitigate the impact of the ongoing public heath crisis, Titan has undertaken a number of key activities during this period, including:

Preparatory work using digital communication techniques to establish relationships with new health care providers ("HCPs") and their staff;
Providing virtual communication tools for HCPs to use with their patients and to highlight the potential benefits of Probuphine as a treatment modality in the increasing telemedicine environment; and
Establishing a social media presence in select geographies to increase awareness of Probuphine and enhance its share of voice in the medication assisted treatment space.
"Our first quarter of 2020 financial results were affected by the COVID-19 pandemic, and we have had to make several adjustments to our commercial tactics to best position Titan in the current environment," said Titan’s President and CEO, Sunil Bhonsle. "We have been working in a virtual environment and have focused our efforts on using digital communication tools to establish strong relationships with the medical community as well as inform patients of Probuphine’s long acting treatment option, which may be well-suited for telemedicine. In addition, our Medical Affairs team continues to develop a virtual process for providing training to health care providers, which, if approved by the FDA, could be a very valuable tool for Titan and health care providers alike."

Probuphine is indicated for the maintenance treatment of OUD in eligible patients.

Please see Full Indication and Important Safety Information below, and link below to Full Prescribing Information.

"The board has been very supportive of the team’s initiative in the face of these new challenges, and I am very pleased with our progress," said Titan’s Executive Chairman, Dr. Marc Rubin. "The unfortunate reality is that patients suffering from OUD are now facing more challenges to getting proper treatment during this pandemic, and we are working hard to ensure we can support their needs, as well as the needs of their health care providers."

First Quarter 2020 Financial Results

For the three months ended March 31, 2020, Titan reported approximately $1.3 million in revenue, which reflects approximately $0.2 million in product sales and approximately $1.1 million related to the Company’s National Institute on Drug Abuse ("NIDA") grant. This compared with revenues of approximately $0.9 million in the same period in 2019, which was comprised of $0.3 million in product sales, $0.3 million related to the amortization of deferred revenue related to the sale to Molteni of the European intellectual property rights to Probuphine and $0.3 million related to the NIDA grant.

Total operating expenses for the first quarter of 2020 were approximately $5.6 million, compared with approximately $5.2 million from the same quarter in 2019, and consisted primarily of research and development ("R&D") and selling, general and administrative ("SG&A") expenses and costs of goods sold, inclusive of distribution expenses. R&D expenses for the quarter ended March 31, 2020 were approximately $2.3 million, compared with approximately $1.8 million for the same three month period in 2019. SG&A expenses for the 2020 first quarter were approximately $3.1 million, essentially unchanged from the same quarter a year ago. Costs of goods sold for the first quarter of 2020 were approximately $0.2 million, compared with approximately $0.3 million in the 2019 first quarter.

Net other expense, consisting primarily of interest expense, non-cash losses on changes in the fair value of warrants and costs attributable to the issuance of warrants was approximately $1.4 million in the first quarter of 2020, compared with net other expense of approximately $0.2 million in the first quarter of 2019.

Net loss applicable to common stockholders in the first quarter of 2020 was approximately $5.6 million, or approximately $0.07 per share, compared with a net loss applicable to common stockholders of approximately $4.5 million, or approximately $0.34 per share, in the same quarter in 2019.

As of March 31, 2020, Titan had cash and cash equivalents of approximately $8.0 million, which the Company believes, together with proceeds from a Paycheck Protection Program loan and the subsequent exercise of warrants, are sufficient to fund planned operations through the third quarter of 2020.

Conference Call Details

Titan management will host a conference call today at 12:00 p.m. ET / 9:00 a.m. PT to review these financial results and discuss business developments in the period. The conference call will be hosted by Sunil Bhonsle, President and CEO; Kate Beebe DeVarney, Ph.D., Executive Vice President and Chief Scientific Officer; Brian Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman.

The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 3367973. The call will also be broadcast live and archived on Titan’s website at www.titanpharm.com/news/events.

About Probuphine

Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

Probuphine was developed using ProNeura, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING INDICATION

PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

IMPORTANT SAFETY INFORMATION

WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE

See Full Prescribing Information for complete Boxed Warning

Serious complications may happen from insertion and removal of PROBUPHINE, including:

•

Nerve or blood vessel injury in your arm

•

Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death

•

Implant sticks out of the skin (protrusion)

•

Implant comes out by itself (expulsion)

Call your healthcare provider right away if:

PROBUPHINE sticks out of the skin or comes out by itself
You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
You have numbness or weakness in your arm after the insertion or removal procedure
You have weakness or numbness in your arm, or shortness of breath
If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

PROBUPHINE is not available in retail pharmacies
PROBUPHINE must be inserted or removed only in the facility of the certified prescriber
Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion. Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you:

Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

These can be signs of an overdose or other serious problems.

Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

Who should not use PROBUPHINE?

Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison’s disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

What should I avoid while being treated with PROBUPHINE?

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death
What are the possible side effects of PROBUPHINE?

PROBUPHINE can cause serious side effects, including:

Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE implants yourself
Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
Physical dependency
Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down
Sleep Apnea. Call your doctor right away if you or someone close to you notices: Observed episodes of stopped breathing or abnormal breathing patterns during sleep
Tell your healthcare provider if you develop any of the symptoms listed.

Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

Common risks with the minor surgical procedure: Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site.