Posts tagged action date
Opioid addiction treatment continues to grab headlines

An article in the latest issue of Guernica, a magazine of art and politics, details the plight of doctors prescribing buprenorphine, a medication for the treatment of opiate addiction.

Unlike methadone, buprenorphine was approved for use in a general office setting. A doctor can apply to get a waiver to prescribe buprenorphine and treat someone suffering with addiction. However, there are severe restrictions on the availability of the medication.

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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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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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