Lotronex alosetron hydrochloride regulatory update

Nestle's Prometheus Laboratories Inc. unit filed a Citizen's Petition asking FDA to provide guidance on how to develop a single, shared REMS and the circumstances under which a party can obtain a waiver from the requirement for a shared REMS. Prometheus is in discussions to develop a single, shared REMS for irritable bowel syndrome drug Lotronex alosetron with generic company Roxane Laboratories Inc., part of Boehringer Ingelheim GmbH (Ingelheim, Germany). Prometheus said it hasn't reached an agreement with Roxane on a shared REMS for the drug - which has a REMS with elements of safe use (ETASU) - due to "unresolved issues." The companies are involved in a patent suit related to Lotronex; patents covering the serotonin (5-HT3) receptor antagonist expire in 2018. Prometheus has U.S. rights to Lotronex from GlaxoSmithKline.

Under the Food, Drug and Cosmetic Act, "a drug that is the subject of an [ANDA] and the listed drug shall use a single, shared system," though the requirement can be waived if FDA determines that the burden of creating the single, shared REMS outweighs the benefit. According to the petition, because the act does not define a single, shared REMS, one possible interpretation is that an innovator and a generic competitor must negotiate and enter into a contract to work together to provide competing drugs. ...