FDA approves Egalet painkiller but label falls short

10 January 2017
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Shares in Egalet (Nasdaq: EGLT) rose sharply as the company received US Food and Drug Administration approval for Arymo ER (morphine sulfate), a new long-acting opioid, before falling back as details of the label were released hours later.

The USA-based specialty pharmaceutical company, which focuses on the development of abuse-resistant formulations of pain medications, had sought to claim that Arymo ER deters abuse through injection, chewing or snorting.

The FDA will allow Egalet to make the first claim, but not the latter two. Shares were up 6% at close of trading on the Nasdaq, but fell again in after hours trading, wiping out any gain from the announcement.

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