Positive Data on VIVUS' Stendra


VIVUS Inc. (VVUS) recently announced encouraging data from a multi-center, placebo-controlled study (TA-501) evaluating the efficacy of Stendra, phosphodiesterase type 5 (PDE5) inhibitor, in men suffering from erectile dysfunction (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.

The company is looking to get the Stendra label updated to include the drug’s efficacy within 15 minutes. Currently, it is recommended that Stendra is to be taken approximately 30 minutes before sexual activity.

We note that the US Food and Drug Administration (:FDA) approved Stendra for ED in Apr 2012. VIVUS is still looking for a partner in the US to market the drug. The company is seeking marketing approval for Stendra (proposed EU trade name: Spedra) for ED in the EU.

According to the company, ED therapies recorded combined sales of over $5.5 billion in 2012. The number is expected to grow in the upcoming 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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