FDA Panel unanimously votes in favor of Collegium’s Abuse-deterrent Analgesic

In fact, Purdue was supposed to appear before the FDA’s advisory panel of analgesic experts on July 7 to review data from its supplemental application for abuse-deterrent OxyContin, but chose to delay the meeting.

The action of the outside advisers to push the green light moves Collegium one step closer to obtain full approval for their new opioid medication.

The vote however comes in contradiction with the FDA staff, which on Wednesday declared its concerns over the oral painkillers that they could be potentially harmful and could be wrongly abused leading to a overdose.

Once approved, Xtampza ER should be taken after meals for maximum benefit.

Earlier in the week, the FDA indicated it has concerns regarding the fact that Xtampza needs to be taken with food in order to work correctly – something that could inadvertently lead to dosing and pain management problems. All this will come into play if the FDA approves the drug. Individuals use this drugs to attain certain euphoric highs and sometimes to disrupt brain control for breathing.

Prescription opioid abuse is an epidemic in the USA, according to the Centers for Disease Control and Prevention (CDC).The CDC estimates that 44 people per day in the US die as a result of overdoses.

The positive response of the FDA advisory panel toward Xtampza may also project a good sign for other pharmaceutical companies such as Acura Pharmaceuticals Inc, KemPharm Inc. and Pernix Therapeutics Holdings Inc, which develop and manufacture abuse-deterrent pain relievers.

Collegium in response has proposed to put a warning on its labels that their drug Xtampza, is a lead drug in development and should only be used after the consumption of food.

The company’s drug, Xtampza ER, is an extended-release formulation of oxycodone that Collegium says is crafted to make it harder to abuse. Zacks downgraded shares of Collegium Pharmaceutical from a “hold” rating to a “sell” rating in a research report on Tuesday, August 25th. They presently have a $28.00 price target on the specialty pharmaceutical company’s stock.