Pharmanovia, the lifecycle management company has signed a licence and supply agreement with Aquestive Therapeutics for its patented diazepam buccal film formulation across the EU, UK, Switzerland, and Norway, as well as countries in the Middle East and North Africa (MENA)– up to 48 markets in total.
Aquestive Therapeutics has been granted tentative approval by the US Food and Drug Administration (FDA), for its diazepam buccal film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older.
Pharmanovia will be responsible for seeking appropriate regulatory approval across EU and MENA.
Pharmanovia CEO, James Burt commented: “Pharmanovia and Aquestive are aligned in our mission to find new and innovative ways to enhance and revitalize iconic medicines. We have extensive experience with diazepam through the Valium brand and, together with Aquestive’s unique PharmFilm technology, we’re intending to bring a novel alternative diazepam delivery option to caregivers and patients at a time of critical need.”
Aquestive Therapeutics CEO Daniel Barber added: “Pharmanovia is experienced in bringing new products to market globally. They are a like-minded collaborator who share our passion and commitment to improving patient treatment and outcomes. Today’s announcement means we are one step closer to bringing a new alternative way to deliver an important treatment, that is convenient and precise to patients.”