Egalet Reports Encouraging Results on Pain Drug Egalet-002

Egalet Corporation EGLT announced top-line results from a category 3 human abuse liability (HAL) study on one of its lead pipeline candidates, Egalet-002. Egalet-002, which is an abuse-deterrent, extended-release, oral oxycodone, is being evaluated for the management of pain severe enough to require daily, round-the-clock opioid treatment and for which alternative treatments are inadequate.

The randomized, double-blind, active and placebo-controlled, five-way crossover study, which was conducted as per FDA guidelines with the goal of comparing the abuse potential of manipulated and intact Egalet-002 versus manipulated immediate-release formulation of oxycodone following oral administration, involved 47 non-dependent recreational opioid users. An exploratory sixth arm was added which compared the abuse potential of Egalet-002 to the currently marketed abuse-deterrent formulation of OxyContin, in 28 non-dependent recreational opioid users.

Results from the study showed that Egalet-002 has the potential to reduce oral misuse and abuse potential of oxycodone when taken by recreational drug users. Moreover, the inability to chew Egalet-002 allows it to be differentiated from other abuse-deterrent opioid products. Following discussions of the study results with the FDA, the company intends to conduct a pivotal oral HAL study on the candidate. Egalet plans to seek approval for the candidate in the U.S. in the second half of 2016.

The announcement of the encouraging results comes a day after Egalet reported positive top-line data from a category 3 intranasal HAL study on another pain candidate, Egalet-001. The company plans to file for its approval in the U.S. later this year.

We note that the market for pain drugs is already crowded given the presence of companies like Mallinckrodt MNK among others. Moreover, new treatments are currently in development including Endo International ENDP/BioDelivery Sciences’ BDSI Belbuca.

Egalet currently carries a Zacks Rank #4 (Sell). Endo is a better-ranked stock in the health care sector carrying a Zacks Rank #2 (Buy).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

To read this article on Zacks.com click here.

Zacks Investment Research