Collegium Falls in Aftermarket Trading After FDA Delays Ruling on Opiod Painkiller
October 12, 2015
By Alex Keown, BioSpace.com Breaking News Staff
CANTON, Mass. – Collegium Pharmaceutical, Inc. ’s stock is down nearly 10 percent in aftermarket trading after the company announced the U.S. Food and Drug Administration will not complete a review of the company’s extended-release opiod pain medication drug Xtampza.
Michael Heffernan, Collegium's chairman and chief executive officer, said the company remains confident in the opiod drug and will work closely with the FDA as it completes its review.
"We look forward to bringing Xtampza ER to market as a potential novel treatment option for patients in need of chronic pain therapy,” Heffernan said in a statement.
closed at$20.09 per share, but in aftermarket trading has fallen to $18.25 per share following news of the FDA’s decision. In its announcement, Collegium did not specify what caused the FDA to delay its new drug application review, nor did it say when the regulatory agency intends to complete the review.
On Sept. 11, a panel of outside advisers recommended unanimously the FDA approve the medication. However, just two days prior to that recommendation, FDA staff members said if the medication was taken without food, it could give insufficient relief and lead to overdosing, Reuters reported. Xtampza ER is designed to be taken with food.
Xtampza ER, Collegium’s lead pipeline candidate, is an abuse-deterrent, extended-release, oral formulation of oxycodone. The drug was designed to manage chronic pain in patients who required daily and long-term opiod treatment. Collegium was working on an abuse-deterrent technology platform called DETERx, which combines oxycodone, the active ingredient in Xtampza ER, with fatty acid and waxes to form small spherical beads the company calls microspheres into a capsule. The wax-based microspheres are “designed to resist particle size reduction and dose dumping when subjected to rigorous physical and chemical manipulation such as breaking, crushing, chewing and dissolving,” Collegium said on its website.
For several years, the FDA has closely watched the opiod drug market due to the ease of which the pain-treating drugs can be abused. In 2013, the regulatory agency established a risk-management plan for extended-release (ER) and long-acting (LA) opioid analgesics, used to treat moderate to severe chronic pain. This plan is designed to ensure that health care professionals are trained on how to properly prescribe these medicines and how to instruct their patients about using them safely.
Opiods, derived from opium, are powerful narcotics that work by changing the way the brain perceives pain. Oxycodone can reach its peak effect on the brain in about 11 minutes, which makes it a prime drug for abuse.
According to analysts at Zack’s, Xtampza ER has the same active ingredient, oxycodone hydrochloride extended-release tablets, as Purdue Pharma’s OxyContin OP, the largest abuse-deterrent opiod in the U.S., which had sales of more than $2.5 billion in 2014.
Several other drug companies are currently developing opiod-based pain relievers, including Pernix Therapeutics Holdings Inc. , Egalet Corp. , KemPharm Inc. , Pain Therapeutics Inc. and Acura Pharmaceuticals Inc. These companies will be closely monitoring the FDA’s decision for Collegium, Reuters said.
At an investor meeting last week, Nektar Therapeutics unveiled its experimental chronic-pain treatment, NKTR-181, a new opiod molecule that has a low abuse liability due to its extended release time, which early trials have shown has a peak-release time of approximately three hours.