VIVUS' Spedra Gets EU Approval - Analyst Blog
) recently announced that the European Commission (EC) has
cleared its drug, Spedra, phosphodiesterase type 5 (PDE5)
inhibitor, for the treatment of erectile dysfunction (ED) in the
EU. The approval did not come as a surprise as, in Apr 2013, the
European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) recommended the approval of the
The approval came on the basis of promising data from three phase III trials REVIVE, REVIVE-Diabetes and REVIVE-RP and a year-long safety study. Investors reacted positively to the news.
We note that the US Food and Drug Administration (FDA) approved the drug under the trade name Stendra for ED in April last year. VIVUS is looking for partners in the US and EU to market the drug.
We note that a few days back VIVUS announced encouraging data from a multi-center, placebo-controlled study (TA-501) evaluating the efficacy of Stendra in men suffering from ED.
The study enrolled 440 patients with mild-to-severe ED with or without diabetes. Data from the study revealed that on an average Stendra was effective after 10 minutes and 12 minutes of taking the 200 mg and 100 mg formulation of the drug, respectively.
According to the company, ED therapies recorded combined sales of over $5.5 billion in 2012. The ED market is expected to grow further in the coming years.
Currently approved PDE5 inhibitors including Pfizer Inc. 's ( PFE ) Viagra and Eli Lilly and Company 's ( LLY ) Cialis are recommended for ingestion one to two hours prior to sexual activity or daily. We believe Stendra's fast action could help the drug gain share once launched. Additionally, it will also help VIVUS to secure a lucrative partnership deal for Stendra in the US and EU.
VIVUS, currently carries a Zacks Rank #3 (Hold). Companies that currently look attractive include Salix Pharmaceuticals ( SLXP ) with a Zacks Rank #1 (Strong Buy).
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