FDA panels vote to reject Pain Therapeutics’ abuse-deterrent opioid drug

pharmafile | June 27, 2018 | News story | Research and Development, Sales and Marketing Remoxy, opioid crisis, opioids, pain therapeutics, pharma 

Drug development firm Pain Therapeutics has revealed that its abuse-deterrent opioid medication Remoxy has been rejected by an FDA advisory panel, which could have drastic consequences on its chances to get the drug approved in the US.

A joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14 to 3 against the drug’s approval. While the US agency is not beholden to the decision, advisory rulings such as these are almost always followed in its final review.

It’s the latest setback for the drug, which was originally filed and knocked back in 2008. The following year, Pain Therapeutics licensed the drug to King Pharmaceutical, who resubmitted it in 2010. Remoxy came under the ownership of Pfizer in 2011 after the firm acquired King Pharmaceutical, but returned the rights to the drug to Pain Therapeutics in 2014, despite previously stating it work to address the issues given in the FDA’s rejection letter.  

Remoxy was licensed by Pain Therapeutics from Durect in 2002. It is delivered in an extended-release capsule gel form designed to prevent it being recreationally abused: its “thick, sticky, high viscosity, hydrophobic, gel formulation” cannot be cut, grated or otherwise divided into smaller particle sizes and resists syringe ability and thus cannot be injected.

Matt Fellows

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