Collegium Pharmaceutical, Inc. COLL announced that the FDA has said that it will not be able to complete reviewing the company’s New Drug Application for Xtampza ER (oxycodone) for the treatment of patients with chronic pain, within the stipulated time.
The FDA was supposed to give a decision on the approval status of the candidate on Oct 12. However, the agency did not provide a new action date.
We remind investors that last month, Xtampza ER was unanimously supported for approval by a couple of FDA advisory panels – the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
Collegium is looking to get Xtampza ER approved 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.
We note that Xtampza is developed using the company’s proprietary DETERx abuse-deterrent technology to address common methods of abuse, including chewing, crushing and/or dissolving, and then taking it orally or snorting or injecting.
The pain management market is highly crowded given the presence of drugs like OxyContin, Opana ER and Targiniq ER among others.
Meanwhile, companies like Endo International plc ENDP and BioDelivery Sciences International, Inc. BDSI are also working on bringing their pain management drugs to market. Currently, their candidate, Belbuca, is under FDA review for the treatment of patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. A response from the FDA is expected this month.
Collegium carries a Zacks Rank #3 (Hold). Nexvet Biopharma Public Limited Company NVET is a better-ranked stock in the health care sector, carrying a Zacks Rank #1 (Strong Buy).
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