US specialty drug company Serenity Pharmaceuticals and Ireland-incorporated Allergan (NYSE: AGN) have agreed to terminate their global agreement for the development and commercialization of Noctiva (desmopressin acetate) following a 90-day transition period.
Moving forward, Serenity will be responsible for commercialization and continued development of the product.
The decision comes just as the US Food and Drug Administration announced the approval of Noctiva nasal spray for the treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times per night to urinate. This marked the first FDA-approved therapy for nocturia.
Desmopressin is an off-patent drug that privately-held Switzerland-headquartered Ferring Pharmaceuticals sells as an oral version and a nasal spray formula under the name DDAVP. Ferring has already received market clearance in more than 65 countries outside the USA for desmopressin orally disintegrating tablets indicated as a treatment for nocturia due to nocturnal polyuria, but so far has failed to gain US approval of its drug for this indication.
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