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Long-acting opioid painkiller Arymo wins FDA approval


(Reuters) — The U.S. Food and Drug Administration said on Monday it has approved Egalet Corp.'s long-acting opioid painkiller, Arymo ER.

The decision follows the recommendation of an independent panel of advisors to the FDA, which in August voted 18-1 in favor of approval. The panel recommended the drug be labeled as an abuse-deterrent product.

The FDA did not immediately say whether it has granted the abuse-deterrent label. Egalet's shares were halted pending news after rising 15% to $9.12 earlier in the day.

The abuse of opioids, a class of drugs that include heroin and prescription painkillers, has reached epidemic proportions in the United States. The Centers for Disease Control and Prevention estimates that 78 Americans die every day from an opioid overdose.

Arymo ER is a long-acting variation of morphine that is intended to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment. It comes in the form of a very hard pill that is difficult to crush and otherwise manipulate by people looking to abuse the product.

Chewing, crushing, dissolving and injecting opioids can increase the speed with which the drugs get into the bloodstream and deliver the sought-after high.

Lawmakers across the United States are seeking ways to stem the epidemic and the FDA is trying to encourage the development of abuse-resistant opioid formulations. The same advisory panel also recommended that the FDA approve a long-acting opioid made by Teva Pharmaceutical Industries Ltd., Vantrela ER.

It also recommended approval of a long-acting, abuse-deterrent opioid made by Pfizer Inc., Troxyca ER, though it had reservations about the drug's ability to curb all forms of abuse.





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