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Pharmaceuticals / Regulatory Affairs

FDA Denies PMRS Petition to Deny Chronic-Use Opioid NDAs

Jan. 4, 2019

The FDA denied a petition from Pharmaceutical Manufacturing Research Services (PMRS) asking the agency to set a higher standard for NDAs for abuse-deterrent opioids for treatment of chronic pain.

PMRS submitted a petition in July calling on the FDA to block any pending and future NDAs with abuse-deterrent labeling and proposed labeling or indications clearing it for chronic use — including Pain Therapeutics’ Remoxy (oxycodone) — absent a “meaningful demonstration” of abuse-deterrent properties under defined legal standards, rather than the methods recommended in FDA guidance.

The FDA’s repeated approval of opioids for chronic pain with insufficient evidence of efficacy is a major driving factor behind the ongoing opioid crisis, PMRS said. “If Remoxy ER is approved with the proposed indication of ‘management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,’ it would be misbranded and its presence on the market would negatively affect the public health, potentially further fueling the current epidemic of opioid addiction,” the petition stated.

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