Egalet Stumbles Over FDA Complete Response Letter

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Egalet Corp. (NASDAQ: EGLT) saw its shares take a dive early on Tuesday after the company announced that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA). The CRL was in regards to the prior approval supplement (PAS) of Oxaydo tabelts C-II in 10mg and 15mg.

For some quick background: Oxaydo is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Oxaydo was originally approved in December 2015 in 5.0 mg and 7.5 mg dosage strengths and is designed to discourage intranasal abuse. Through its formulation, Oxaydo contains inactive ingredients that may cause nasal burning if manipulated and snorted. However, there is no evidence that Oxaydo has reduced abuse liability compared to immediate-release oxycodone.

The most frequent adverse reactions to the drug are nausea, constipation, vomiting, headache and pruritus. The more severe and less frequent adverse reactions include respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and shock.

Ultimately it seems that the FDA has issued the CRL because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, for Oxaydo.

Excluding Tuesday’s move, the stock is actually down 62% year to date. Over the past 52 weeks, the stock is down only 43%.

Shares of Egalet were last seen down 15.3% at $2.43, with a consensus analyst price target of $12.33 and a 52-week range of $2.03 to $10.00.