American drug maker Collegium Pharmaceutical Inc. reported that the U.S. Food and Drug Administration (FDA) would not be able to release its complete review of the firm's opioid painkiller, Xtampza, on Monday.
The Massachusetts-based company did not say whether the food and drug agency had provided any reason for failing to finish its review by the Oct. 12 deadline, or when it expects the review to be completed.
"We are confident in the Xtampza ER program and our NDA submission. We continue to work closely with the FDA as they complete their review," Michael Heffernan, chairman and CEO of Collegium, said.
"We look forward to bringing Xtampza ER to market as a potential novel treatment option for patients in need of chronic pain therapy."
Xtampza, Collegium's experimental oral painkiller, is designed to be taken by individuals after a meal in order to benefit from its maximum effect.
Its active ingredient, oxycodone, has been approved by the FDA and other international regulators for use in different quick-release and extended-release medicinal products.
The drug was developed through Collegium's own abuse-deterrent technology called DETERx meant to address common abusive methods such as chewing, crushing, or dissolving, and then taken by individuals either through orally, injecting or snorting.
A Food and Drug Administration panel, consisting of outside advisers, had voted unanimously in favor of approving the use of the drug in September.
However, it had failed to consider crucial information from the staff of the FDA mentioning that if Xtampza was taken without food, individuals would not be able to benefit fully from the drug's pain relieving effect. The agency also believes this could lead to overdosing among Xtampza users.
Experts have long considered the abusive use of opioids, which is a class of medicines that include heroin and other prescription painkillers, to be a significant health concern. A person who overdoses on such drugs often experience euphoric highs and a disruption in their brain's ability to control their breathing.
The anticipated release of the Food and Drug Administration's ruling on Xtampza will be monitored closely by developers of other abuse-deterrent painkillers.
These pharmaceutical firms include Egalet Corp., Pain Therapeutics Inc., Acura Pharmaceuticals Inc., Pernix Therapeutics Holdings Inc. and KemPharm Inc.
Meanwhile, Collegium's market shares dropped by as much as eight percent in extended trading. Its shares were trading at around $18.25 after the bell and closed at $20.09.
Photo: Kurtis Garbutt | Flickr
