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PTI's Remoxy: US FDA Panel To Weigh Intranasal Abuse Deterrence Against Oral Abuse Potential

 
• By Sue Sutter

Agency reviewers see lower potential for intranasal abuse with Pain Therapeutics' extended-release opioid compared to immediate-release oxycodone, but an increased abuse potential when Remoxy is chewed compared to swallowing the drug intact.

The US FDA will ask its external experts whether the decreased likelihood of intranasal abuse with Pain Therapeutics Inc.’s long-acting opioid Remoxy ER (oxycodone extended-release) is outweighed by public health concerns about the drug’s potential for oral abuse.

The agency’s Anesthetic and Analgesic Drug Products Advisory Committee, along with the Drug Safety and Risk Management Advisory Committee, meets June 26 to give their verdict on the approvability of Pain Therapeutics (PTI’s) Remoxy and whether the data support abuse-deterrent

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