A new experimental opioid painkiller is inching closer to approval as continued support is being given for further trials.
Collegium Pharmaceutical Inc has received another approval from a panel of outside advisers to the U.S. Food and Drug Administration (FDA). The panel unanimously voted in favor of the drug.
But on Wednesday, the FDA showed some concern over the oral medication, worried that there could be an overflow of overuse or misuse of the drug which would inevitably lead to overdoses.
But this did not sway the panel. They voted 23 to 0 in favor of approving the drug. However, this does not mean that the FDA has to follow the panel’s decision. They are there to investigate and provide their best advice as an advisory panel. In most cases though, the FDA does take their opinion heavily, according to Reuters.
The drug is a long-acting experimental oxycodone pill that will be sold under the name Xtampza if it is approved. The drug will be instructed to be taken after a meal in order to provide the best pain relief. This would be an important instruction for patients as the FDA has found that if it is taken without food, it would not provide as much pain control for the patient which could lead some to taking more doses which could mean a large amount of overdoses.
Opioids are in the same class as heroin and prescription painkillers. The abuse of these types of drugs has been a long, on-going concern. The overdose of these drugs can lead to euphoric highs and often disrupt parts of the brain that control breathing.
The Centers for Disease Control and Prevention say that in the United States, an estimate 46 people die everyday from overdosing on opioid painkillers.
In order to support proper use of the drug, Collegium has suggested that they make it very clear on the label that Xtampza should only be taken with food.
Even with only the FDA panel’s supportive vote for approving Xtampza, it is a gateway for other companies to begin developing abuse-deterrent versions of painkillers.
Pernix Therapeutics Holdings Inc, Egalet Corp, KemPharm Inc, IntelliPharmaCeutics International Inc, Pain Therapeutics Inc and Acura Pharmaceuticals Inc all are in the process of creating abuse-deterrent painkillers.
Another panel of the FDA voted against approving Purdue Pharma’s fast-acting opioid painkiller on Thursday because of high concerns of overdosing possibilities.