Duchesnay submits supplemental NDA with the US FDA for Osphena (ospemifene) for treating moderate to severe dyspareunia.
Global Banking News-October 24, 2018-Duchesnay submits supplemental NDA with the US FDA for Osphena (ospemifene) for treating moderate to severe dyspareunia
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Pharmaceutical company Duchesnay Inc said on Tuesday that it has filed its supplemental New Drug Application with the US Food and Drug Administration (FDA) seeking a new indication for Osphena (ospemifene) for moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
This US FDA application is based on the company's new safety and efficacy data acquired through a confirmatory phase 3 randomized, double blind, placebo-controlled multicenter study evaluating the efficacy and safety of ospemifene in patients with moderate to severe vaginal dryness.
The company has collected a significant amount of data regarding ospemifene, including ten phase 2 and 3 studies. This data is currently under evaluation by the US Food and Drug Administration.
In conjunction, the US FDA's action date to complete its review of the application under the Prescription Drug User Fee Act is 26 January 2019.
According to the company, Osphena is the only US FDA-approved oral pill for the treatment of moderate to severe dyspareunia (painful sex), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. It is not an estrogen, but helps improve specific vaginal tissues and relieves moderate to severe painful sex due to menopause.
A potential additional indication for Osphena, the treatment of vaginal dryness, is currently under review by the US FDA, concluded the company.
((Distributed via M2 Communications - http://www.m2.com))
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|Publication:||Global Banking News (GBN)|
|Date:||Oct 24, 2018|
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