Avadel Pharmaceuticals has announced the launch of Noctiva desmopressin nasal spray for the treatment of nocturia due to nocturnal polyuria (overproduction of urine at night) in adults.
Avadel acquired US and Canadian rights to Noctiva from Serenity Pharmaceuticals in September 2017 for $50 million up front, plus milestone payments and royalties. A $20 million payment is due at the time of the full commercial launch.
Noctiva was approved by the FDA in March 2017 with a boxed warning about the risks of hyponatremia.
In 2010, Allergan licensed the desmopressin nasal spray, then called SER120, from Serenity; that deal was terminated in March 2017, around the time of the FDA approval and several months after a positive recommendation from The FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) when Allergan implied that it was committed to development of the product.
Avadel CEO Michael Anderson said, “We’re committed to getting patients the help they need to improve their quality of life. We’re working with specialists to provide a safe and effective treatment option to patients who suffer from nocturia due to nocturnal polyuria.”
Read the Avadel press release.
