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FDA Explains Reasons for Refusing to Approve Another Oxycodone Drug

Posted 12 February 2018 | By Zachary Brennan 

FDA Explains Reasons for Refusing to Approve Another Oxycodone Drug

The US Food and Drug Administration (FDA) on Monday offered an explanation for refusing to approve Pharmaceutical Manufacturing Research Services, Inc.’s (PMRS) new drug application (NDA) for its oxycodone hydrochloride (HCl) immediate-release (IR) oral capsules.

The notice, published in Monday’s Federal Register, offers PMRS an opportunity to request a hearing on the matter and follows the agency’s decision to reject a citizen petition filed by the Pennsylvania-based company in May 2017 to stay the approval of Insipirion’s recently approved opioid RoxyBond (oxycodone hydrochloride).

On 31 October 2017, PMRS filed an action for declaratory and injunctive relief against FDA in the US District Court of Eastern Pennsylvania, claiming the agency had failed to respond to certain relevant arguments.

Among other charges, PMRS said FDA offered no response to its position that FDA relied on human abuse potential studies in approving RoxyBond, which PMRS said are “inherently flawed.” PMRS also filed a complaint in the same court in August. And since February 2016, PMRS has filed fourt citizen petitions with FDA.

FDA’s CRL and Explanation

FDA explained the CRL it sent to PMRS in November 2017, offering a few reasons for why the opioid is not abuse-deterrent, including because “the data submitted were not sufficient to rule out the possibility that the proposed formulation could result in a greater proportion of abuse by injection of PMRS’s product compared to a conventional IR oxycodone formulation.”

The agency also said PMRS has not provided sufficient data to show that the product would be safe and has not shown that “the methods used in, and the facilities and controls used for the manufacture, processing, or packing of the product are adequate to preserve its identity, strength, quality, and purity.”

Federal Register


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