The U.S. Food and Drug Administration (FDA) panel has approved the experimental painkiller drug of Collegium Pharmaceutical Inc., called Xtampza ERTM. The drug-manufacturing company announced the news on Friday, Sept. 11 through a press release on their website.
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 results of the panel votation was 23 to 0 in favor of approving the drug. This is opposite of the FDA staff recommendation, which expressed concerns of possible overdose due to wrong administration should the drug be approved. Although the FDA is not compelled to follow the decision of the advisers, the agency typically does.
Xtampza ERTM is an oral, abuse-deterrent oxycodone prepared in extended-release capsules. This drug is indicated for the treatment of severe pain that warrants long-term administration of opioid therapy that must be provided in a daily, round-the-clock basis. Patients who cannot be relieved by other treatment modalities may also benefit from this medication.
Collegium is highly pleased that the advisory panel of the FDA has voted in favor of Xtampza ERTM, said Michael Heffernan, the chairman and CEO of the company. They are looking forward to collaborating with the FDA through the final stages of the review.
Once approved, Xtampza ERTM should be taken after meals for maximum benefit. According to the FDA staff, administration of the long-acting opioid drug on an empty stomach may result in adequate pain relief and thus bring up the possibility of misuse and overdose. Collegium has already proposed to put a clear label on the Xtampza packaging regarding the need to eat prior to taking the drug.
Opioid abuse has been a cause of concern for a long time now. The drugs, which include heroin and other prescription pain relievers, may cause euphoria and respiratory difficulties as the drugs may disturb the area of the brain that controls breathing.
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. However, this may not always be the case as Purdue Pharma's fast-acting opioid drug has been disproved by another FDA advisory committee on Thursday, Sept. 10.
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