Recently, Vivus, Inc. (VVUS) announced encouraging phase III results from a study that was conducted with avanafil in type I and type II male diabetes patients suffering from erectile dysfunction (ED).
Avanafil, a PDE5 inhibitor, met all the primary endpoints of the study, which was conducted to evaluate the efficacy and safety of the candidate. In addition to meeting the primary endpoints, the candidate showed a favorable side effect profile.
The Revive-diabetes (TA-302) study is one of the four randomized, double blind, placebo-controlled late-stage avanafil trials. The study involved about 390 men suffering from diabetes and ED.
Diabetes is one of the most common causes of ED with diabetic men being more prone to have ED than non-diabetic men.
Recently, Vivus presented positive results from another phase III study with avanafil for the treatment of diabetes patients with ED.
Avanifil’s efficacy, fast onset-of-action and safety profile could help the drug gain share once launched. Patients may achieve successful intercourse in about 15 minutes and beyond six hours after being dosed with avanafil.
However, the product will face tough competition from Pfizer’s (PFE) Viagra, Eli Lilly’s (LLY) Cialis and Glaxo’s (GSK) Levitra. Worldwide sales of PDE5 inhibitor products for the treatment of ED were more than $3.8 billion in 2009, with Viagra accounting for a whopping $1.9 billion. Cialis posted sales of $1.6 billion.
Apart from avanafil, VIVUS has other candidates in different stages of clinical development, including lead pipeline candidate Qnexa for the treatment of obesity, type II diabetes and obstructive sleep apnea (OSA).
Qnexa is currently under US Food and Drug Administration (FDA) review with a decision expected later this year. Obesity is an attractive market that could be worth many billions of dollars. It is estimated that obesity affects over 400 million people globally. Moreover, obesity is linked to increased health risk. Given the huge unmet need in this market, the successful development of the obesity pipeline would help drive growth at VIVUS.
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