Egalet Corp. (NASDAQ:EGLT) has received tentative approvals to use expanded labels for some of its tablets. The Food and Drug Administration recently allowed the firm to use new labels for its drug, ARYMO Extended Release tablets C-II, also known as morphine sulphate. Following the tentative approval, Egalet will include category 2/3 datafrom a study on intranasal human abuse potential (HAP) in the new labels, which will also feature abuse deterrent data.The company expects a final approval in October 2018, when the patent exclusivity that was given to another company expires. Technically, the Food and Drug Administration tentatively approves generic drugs which are due for approval before the expiration of exclusivities and patents on its reference list.
Egalet Chief Operating Officer Mark Strobeckhailed the inclusion of abuse deterrent data on ER morphine, a frequently prescribed drug for chronic pain which has a history of being abused by patients.The drug comes in easy formulations which can be abused. Becauseof the riskof abuse, the company believes that the inclusion of abuse data is a significant improvement which will benefit patients with chronic pain.
In January, the FDA approved morphine ER, which is made using Egalet’sGuardian Technology for use in management of severe pain. This was followed by the approval of Vantrela, another opioid whose labels included abuse deterrent data.Egalet is minimizing the usage of it’s extended release morphine, restricting its usage to patients with chronic pain that requires round the clock attention, or to those whose other pain management drugs have failed.Ideally, opiods have in the past been abused by patients, leading to death in extreme cases. Egalet uses it’s proprietary technology to manufacture most abuse deterrent prescription medicine.
Following the approval, Egalet’s stock responded positively, surging 26% on December 15.