Here are five things to know:
1. In September, The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee unanimously decided to support the approval of the product for managing severe pain.
2. The drug meets all of the FDA’s mandated quality, safety and efficacy standards for approval. However, Stamford, Conn.-based Purdue Pharma filed patent litigation for the drug earlier this year, which subjects the drug to an automatic stay of up to 30 months.
3. In the claim, Purdue Pharma says Xtampza ER infringes three Orange Book-listed patents. The U.S. District Court for the Southern District of New York recently found the patents invalid. The patents are currently under appeal.
4. Chairman and CEO of Collegium, Michael Hefferman, said, “We are very pleased that the FDA has granted tentative approval for Xtampza ER. The FDA has recognized that Xtampza ER has abuse-deterrent properties consistent with FDA’s final guidance titled, “Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling.”
5. The drug cannot be transformed into an immediate-release form, even if it is crushed or chewed, leading many professionals to believe the drug will deter opioid-abuse.
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