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Pharmaceutical industry

Collegium Pharmaceutical Receives Tentative FDA Approval for Xtampza ER

Strategic Insights

— 1 min read

Collegium Pharmaceutical, a Massachusetts-based specialty pharmaceutical company, has received tentative approval from the United States Food and Drug Administration (FDA) for its new drug application (NDA) for Xtampza ER, a medication designed to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment. The FDA has recognized Xtampza ER's abuse-deterrent properties, consistent with its guidance titled "Abuse-Deterrent Opioids - Evaluation and Labeling." However, the FDA's tentative approval is subject to a 30-month stay due to patent litigation filed by Purdue Pharma, L.P. against Collegium. The product can be marketed once Collegium receives a court order stating the listed patents are invalid or not infringed, or if Collegium settles the Purdue litigation prior to the 30-month period.

Key Takeaways:

  • Xtampza ER has been granted tentative approval by the FDA for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
  • The FDA has recognized Xtampza ER's abuse-deterrent properties consistent with its guidance titled "Abuse-Deterrent Opioids - Evaluation and Labeling."
  • Collegium Pharmaceutical is confident that Xtampza ER does not infringe the three patents that Purdue Pharma has asserted against them.
  • Xtampza ER could provide a unique extended-release, abuse-deterrent treatment option for patients with chronic pain and dysphagia.
  • The product's DETERx oral drug delivery technology is designed to provide extended-release delivery, unique abuse-deterrent properties, and flexible dose administration options.
  • Xtampza ER is in development for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
  • Corinthian is developing Xtampza ER using its proprietary DETERx technology platform to address common methods of abuse, including chewing, crushing and/or dissolving, and then taking it orally or snorting or injecting.

Statistics:

  • The FDA has placed a 30-month stay on the final approval of Xtampza ER due to patent litigation filed by Purdue Pharma, L.P. against Collegium.
  • Xtampza ER has been designed to provide extended-release delivery, unique abuse-deterrent properties, and flexible dose administration options.
  • The proposed number of patients that may benefit from Xtampza ER is not explicitly stated.

Sources:

  • GlobeNewswire - Collegium Pharmaceutical, Inc. Receives Tentative Approval for New Drug Application for Xtampza ER
  • Securities and Exchange Commission (SEC) - Current Report on Form 8-K filed by Collegium Pharmaceutical, Inc. on June 19, 2015

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