The FDA has delayed approval of Avadel Pharmaceuticals' narcolepsy medication until 2023 due to a patent issue.
This week, the company disclosed the delay in a regulatory filing. The application for FT218 has been put on hold while Avadel adds a certification to its Risk Evaluation and Mitigation Strategies (REMS) patent, which the FDA deemed improper.
REMS patents are used for medicines that require a REMS programme, in which the FDA mandates a mitigation plan for medications with substantial safety concerns but possible benefits that outweigh that risk. Patents allow a corporation to demonstrate that it is in compliance with any REMS regulations.
After the patent expires, any business that wants to market a generic version of the drug must demonstrate compliance with the REMS safety criteria.
Before approving FT218, the FDA would like to see an additional certification to the REMS patent added to the new medication application.
Avadel currently anticipates that the therapy will be approved on or before June 17, 2023, when the REMS patent expires. The FDA does not have to wait for that date and could approve FT218 sooner, according to the business. Avadel's stock dropped 48% to $1.72 on Thursday morning, from a previous closing of $3.38.
This is the latest setback in Avadel's quest to obtain approval for FT218.