Posts tagged drug delivery platform
Braeburn provides update on training sessions for Probuphine

Healthcare provider training and certification for Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant will take place on July 15-17 in Denver by Titan’s marketing partner, closely-held Braeburn Pharmaceuticals.

The FDA cleared Probuphine in late May as the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less a day. Opioid use disorder is a chronic brain disease and one of the fastest growing public health epidemics in America.

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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 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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