Avadel Pharmaceuticals Announces Journal of Urology Publication of Phase 3 Data on NOCTIVA
Avadel Pharmaceuticals (Nasdaq:AVDL), a company focused on providing innovative medicines for chronic urological, central nervous system, and sleep disorders, announced today that the Journal of Urology, official journal of the American Urological Association, recently published results from pivotal Phase 3 clinical trial data on NOCTIVA (desmopressin acetate) Nasal Spray, the lowest effective dose of desmopressin. As quoted in … Continued
Avadel Pharmaceuticals (Nasdaq:AVDL), a company focused on providing innovative medicines for chronic urological, central nervous system, and sleep disorders, announced today that the Journal of Urology, official journal of the American Urological Association, recently published results from pivotal Phase 3 clinical trial data on NOCTIVA (desmopressin acetate) Nasal Spray, the lowest effective dose of desmopressin.
As quoted in the press release:
These data showed that treatment with NOCTIVA resulted in significant reductions in nocturic episodes in patients with nocturia. Additionally, NOCTIVA showed improvements in patients’ quality of life (QoL) and had a well-tolerated safety profile. These results demonstrate that NOCTIVA is an effective treatment for adults with nocturia due to nocturnal polyuria.
“We are extremely pleased that these pivotal results on NOCTIVA were published in the well-respected Journal of Urology,” said Greg Divis, Chief Operating Officer of Avadel Pharmaceuticals. “We understand how disruptive nocturia can be for patients and are proud to have recently launched NOCTIVA, the first product approved by the FDA for nocturia due to nocturnal polyuria.”
Noctiva is a proprietary emulsified formulation of desmopressin that uses a unique permeation enhancer to deliver a microdose of desmopressin. It is the lowest effective dose of desmopressin approved by the FDA to treat nocturia in adults due to nocturnal polyuria, which causes patients to wake two or more times per night to urinate. Nocturia affects an estimated 50 million Americans1and can have an adverse impact on QoL and overall health with an increased risk of diabetes, hypertension, depression, injury due to falls, and decreased daytime functioning and work productivity.
