America’s Food and Drug Administration has confirmed that it has now approved the long-acting painkiller Arymo ER. Developed by Egalet, the much-awaited painkiller is based on opioids and was approved after a prolonged consideration process.
An independent advisory panel was appointed for the task and approved the drug by a margin of 18-1. One of its recommendations was that it be manufactured and labelled for use as a deterrent medication for drug abuse. The FDA has not yet confirmed, however, whether it will approve the label of abuse-deterrent.
Egalet’s shares rose after the announcement of the drug approval, after being paused pending the news.
A Drug Epidemic in the USA
Opioid abuse has reached truly epidemic levels in the USA. This category of drugs includes prescription painkillers and heroin. The Center for Disease Control & Prevention estimates that nearly 80 Americans are dying daily from opioid drug-related abuse.
The new drug, Arymo ER, is a morphine derivative with long-lasting effects. It treats severe pain for long periods of time. The drug’s format is designed to be very hard and difficult to crush, making it very difficult to abuse or manipulate.
Dissolving, chewing, crushing and injecting opioid drugs will accelerate the rate at which the active ingredients are delivered into the bloodstream, which delivers the addictive ‘high’.
Opportunities for Manufacturers
For any other firms asking how long does it take to get a FDA 510k approved, the news is ultimately positive but does stand as a reminder of the challenges and time scales required to get a drug to market. Many of these biotech development firms will use a third-party review company that can help them to get the process right and ensure there are no delays due to application errors. Companies such as http://www.fdathirdpartyreview.com/ offer specialist services in this regard. There is a particular drive to get opioid treatment drugs to market which cannot be tampered with to achieve a high.
American lawmakers are desperately seeking ways of stemming the drug addiction epidemic, and the FDA is working hand in hand with the government to develop opioid drugs which are resistant to abuse. The same advisory panel recommended to the FDA that it also approve a similar long-acting drug, Vantrela ER, which is manufactured by Teva Pharmaceutical Industries Ltd.