FDA: PMRS Oxycodone NDA Did Not Include Enough Data on Abuse-Deterrent Properties
The FDA declined to approve a Pharmaceutical Manufacturing Research Services NDA for a new oxycodone hydrochloride product due to insufficient evidence of its abuse-deterrent properties, the agency said a Feb. 12 notice.
The agency sent PMRS a complete response letter in November noting the application featured an oxycodone formulation that can be easily extracted in commonly available solvents into a solution suitable for injection. The company also failed to provide sufficient data to prove the presence of excipients in the formulation can deter abuse, and the data did not prove the product was “meaningfully resistant to manipulation for misuse or abuse,” the agency said.
The company also did not provide data, including pharmacokinetic and human abuse liability study findings, that fully characterized the product’s potential for all routes of abuse, and the data it did submit did not adequately rule out the possibility the proposed formulation could result in more abuse via injection than a conventional oxycodone formulation.