A clinical abuse potential study of REMOXY ER.
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 26 Jun 2018
At a glance
- Drugs Oxycodone (Primary)
- Indications Pain
- Focus Adverse reactions; Registrational
- Sponsors Pain Therapeutics
- 26 Jun 2018 In a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA), majority of the members (14/3) voted against the approval of oxycodone controlled-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, according to a Pain Therapeutics media release.
- 19 Mar 2018 According to a Pain Therapeutics media release, the company announces FDA Advisory Committee Meeting to discuss the New Drug Application (NDA) for REMOXY ER.
- 01 Mar 2018 According to a Pain Therapeutics media release, the U.S. Food and Drug Administration (FDA) has determined that a New Drug Application (NDA) for REMOXY ER is sufficiently complete to permit a substantive review. The FDA has set an action date of August 7, 2018 under the Prescription Drug User Fee Act (PDUFA). The Company believes the FDA will hold an open advisory committee meeting to discuss REMOXY ER.