Dr. DeVarney, a clinical neuropsychologist by training, joined Titan in January 2007 and spearheaded the development of Probuphine® implant, the first six-month long acting product approved in the United States, Canada and Europe for the treatment of opioid use disorder in eligible patients.
| SOUTH SAN FRANCISCO, Calif., Dec. 30, 2019 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that at its recent annual stockholders meeting, Kate DeVarney, Ph.D., its Executive Vice President and Chief Scientific Officer, was elected to the Company’s Board of Directors.
Dr. DeVarney, a clinical neuropsychologist by training, joined Titan in January 2007 and spearheaded the development of Probuphine® (buprenorphine) implant, the first six-month long acting product approved in the United States, Canada and Europe for the treatment of opioid use disorder in eligible patients. Prior to joining Titan, she served as Senior Director at Corcept Therapeutics and as Senior Medical Director for Neurosciences within World Wide Human Health at Merck & Co. Dr. DeVarney also held positions within the Neurosciences research and development and medical affairs organizations of SmithKline Beecham and GlaxoSmithKline. Throughout her academic and industry careers, Dr. DeVarney’s research has focused primarily on addiction; neurodegenerative disorders, including Alzheimer’s disease and Parkinson’s disease; mood and anxiety disorders; metabolic disorders and obesity. “Kate’s leadership of the clinical development and medical affairs team at Titan is greatly valued by all, and we welcome her as a Board member and look forward to her future contributions to the growth of the company,” said Titan’s Executive Chairman, Dr. Marc Rubin. “I would like to take this opportunity to thank Dr. Rajinder Kumar, who retired from the Board in December, for his contributions to Titan over the past several years, and wish him the best in his future endeavors.” 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. IMPORTANT SAFETY INFORMATION
Call your healthcare provider right away if:
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.
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?
What are the possible side effects of PROBUPHINE? PROBUPHINE can cause serious side effects, including:
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. Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL. Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The company’s lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson’s disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com. Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management’s current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan’s ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. CONTACTS: Sunil Bhonsle Stephen Kilmer
SOURCE Titan Pharmaceuticals, Inc. | |||||
Company Codes: NASDAQ-SMALL:TTNP |
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