In regulatory news:

The FDA 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 FDA did not immediately say whether it has granted the abuse-deterrent label, in line with the panel’s recommendations. The drug is a long-acting variation of morphine that is pressed into a very hard pill that is difficult to crush and otherwise manipulate. The news comes as the country is in the midst of an opioid crisis which the CDC estimates kills 78 Americans every day.

More info via Business Insurance here.

Leave a Comment

Your email address will not be published. Required fields are marked *