Posts tagged maintenance treatment
Braeburn presents Probuphine data at CPDD meeting

Closely-held Braeburn Pharmaceuticals has presented data from the poster of the Phase 3 study of Probuphine, a six-month subdermal buprenorphine implant for the long-term maintenance treatment of opioid dependence, at the annual scientific meeting of The College on Problems of Drug Dependence (CPDD).

The FDA recently approved Probuphine, which was developed by its partner, Titan Pharmaceuticals (NASDAQ:TTNP), on May 26.

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Titan Pharma receives milestone on Probuphine approval

Titan Pharmaceuticals (NASDAQ:TTNP) has received a $15-million milestone payment from development and commercialization partner, Braeburn Pharmaceuticals, following FDA approval of Probuphine, the first six-month maintenance treatment of opioid dependence.

Under terms of the licensing agreement, closely-held Braeburn will pay Titan tiered royalties on net sales in the U.S. and Canada at rates ranging from the mid-teens to low-twenties. In addition, Titan is eligible for up to $165-million in milestone payments based on achievement of certain annual sales targets.

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Titan Pharma presents Phase 3 Probuphine data

Titan Pharmaceuticals (NASDAQ:TTNP) has presented data from the last Phase 3 study of Probuphine, a six month subdermal buprenorphine implant for the long-term maintenance treatment of opioid addiction, at a poster session during the 47th Annual American Society of Addiction Medicine Annual Conference.

The data indicate that participants who were clinically stable on sublingual buprenorphine at a dose of 8 mg or less per day maintained stability when transferred to Probuphine, and that they were more likely to sustain abstinence from illicit opioids throughout the six months than participants who remained on sublingual buprenorphine.

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Titan Pharma receives FDA feedback on Parkinson’s implant

The FDA has provided written feedback to Titan Pharmaceuticals (NASDAQ:TTNP) on the initial development plan for its proprietary ropinirole hydrochloride implant for Parkinson’s disease.

Based on the FDA’s feedback on the development plan submitted in December 2015, Titan is proceeding with the required non-clinical studies to support a potential IND submission in the fourth quarter of 2016, followed by an initial pharmacokinetic and proof-of-concept clinical study. Titan is pursuing a 505(b)(2) registration pathway for the implant.

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Titan’s Probuphine continues to build media attention

WMUR Channel 9 in Manchester, NH has produced a segment about Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction.

The news segment quotes Dr. Andy Mendenhall, regional director for CleanSlate, who says Probuphine is implanted under the skin via a “very, very simple incision” and is effective for six months.

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FDA extends Probuphine action date

The FDA has extended its action date to consider approval of a NDA for Probuphine for the maintenance treatment of opioid addiction by the standard period to May 27 from Feb. 27.

Following the Psychopharmacologic Advisory Committee meeting in January, which recommended approval of Probuphine, the FDA requested additional changes to the Risk Evaluation and Mitigation Strategy (REMS) portion of the NDA, which were promptly submitted by Titan Pharmaceuticals’ (NASDAQ:TTNP) development and commercialization partner, closely-held Braeburn Pharmaceuticals.

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Titan’s Probuphine attracts more media attention

The New York Times has published an article about addiction medicines that includes a segment about Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction.

The article quotes Richard Rosenthal, medical director of addiction psychiatry at Mount Sinai Behavioral Health System in New York, who discusses how Probuphine solves three problems associated with opioid maintenance therapy.  The first is the chance of resale or accidental exposure to the pills. “Also, there’s the opportunity for non-adherence — people forget, or don’t take their dose, which leaves them vulnerable again,” he said.  “The other issue mentioned is that medicines have peaks and troughs. “People on various medications may have increased cravings during those troughs.”

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FDA adcom votes in favor of approving Titan’s Probuphine

The Psychopharmacologic Drugs Advisory Committee of the FDA voted 12-to-5 in favor of approving Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine.

The committee’s vote followed presentation and discussion of data regarding Probuphine’s efficacy, safety, and risk-benefit profile. The FDA accepted the NDA for Probuphine last September and set an action PDUFA date for Feb. 27.

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