VIVUS Inc, a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, reported its highlights and financial results for the first quarter ended March 31, 2010.
On January 7, 2010, the company announced positive results from a phase 2 study evaluating the safety and efficacy of Qnexa, an investigational product candidate, for the treatment of obstructive sleep apnea (OSA). This study demonstrated statistically significant improvement in the apnea/hypopnea index (AHI) in patients with OSA treated with Qnexa for 28 weeks. Qnexa-treated patients on average had a 69% reduction in sleep apnea and hypopnea events as compared to patients on placebo (ITT-LOCF P <0.001 active vs placebo).
"The highlight of the quarter was the acceptance of the Qnexa NDA and the notification of the tentative Advisory Committee meeting on July 15, 2010. We look forward to discussing the results of the phase 3 studies with the Advisory Committee," said Leland Wilson, CEO of VIVUS. "Early in the quarter, we reported positive results from the phase 2 study of Qnexa in obstructive sleep apnea, a serious unmet medical need. Obstructive sleep apnea is now the third potential indication for Qnexa and we are working with the FDA to design a phase 3 program.”
The company also released financial information stating that total revenue for the first quarter of 2010 was $1.7 million as compared to $22.2 million for the first quarter of 2009.