FDA

Regeneron pain study put on hold by the FDA

The US Food and Drug Administration has halted a clinical trial into the efficacy of the potential new painkiller fasinumab. This injectable analgesic is being developed by Teva Pharmaceutical Industries Ltd and Regeneron Pharmaceuticals Inc as a possible alternative to using opiates.

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The study was stopped in the middle stage of a trial on patients with chronic and severe back issues needing pain management. The catalyst was observing damage to joints in a patient with severe osteoarthritis who had been given a large dose of fasinumab.

Obstacles

The announcement was made on October 17, 2016, and it indicates that fasinumab may suffer from developmental problems that have plagued similar products. After the news predicted the likelihood of the drug’s success was reduced, this appeared to have a negative impact on Regeneron’s stock price. The collaboration between Regeneron and Teva to develop fasinumab, as reported by Reuters, was only announced last month.

Alternative treatment

Medical professionals have been concerned about the overuse of opioid painkillers because even though they are effective, they are also open to abuse and have many risks associated with addiction and overdosing. Fasinumab was planned to serve as another form of effective pain relief by blocking nerve growth factor (NGF), which is a transmitter involved in the communication of pain.

Analysis to date had showed relief of pain in patients taking fasinumab compared to those taking a placebo. It is thought that Teva and Regeneron will now discuss another study with the FDA for testing fasinumab that will exclude sufferers of osteoarthritis. Regeneron has invested years in trying to devise a safe medication to block NGF. Fasinumab had already suffered a blow in 2012, when a study on animals had indicated that they were suffering nerve damage and the trial was put on hold. That particular trial has since been allowed to resume.

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It appears that significant research and more clinical trials will still be necessary before fasinumab will be allowed on to the market in any form for prescription to patients. While physicians may clamour for an alternative to pain relief derived from opiates, it does not look like their wish will be granted just yet.

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