A issued the CRL to communicate its decision that the NDA could not be approved in its present form. The CRL included the following areas: clinical, labeling, REMS, safety update, and drug scheduling. We held a meeting with the FDA on January 19, 2011, to discuss the items contained in the CRL. At this meeting the FDA requested that we assess the feasibility of performing a retrospective observational study utilizing existing healthcare databases to review fetal outcomes in the offspring of women who received 100mg of topiramate for migraine prophylaxis during pregnancy. In the QNEXA studies, which included 15 births from women exposed to topiramate, there were no reports of any adverse fetal outcomes.
We expect to reach agreement with the FDA, and if deemed feasible, initiate the retrospective observational study on fetal outcomes within the next two months. We will provide more details as soon as an agreement is reached. It is our goal to resubmit the NDA for QNEXA by the end of 2011.
Although no other requests for additional information or studies were made by the FDA at the meeting, there can be no assurances that the FDA will not request or require us to provide additional information or undertake additional studies in connection with the QNEXA NDA.
"In 2010, we also made significant progress with the development of QNEXA as a treatment for obesity by filing for approval in the European Union, and for avanafil we completed the pivotal phase 3 studies," stated Leland Wilson, chief executive officer of VIVUS. "We are working diligently on responding to the FDA's request to assess the feasibility of conducting a retrospective observational study. Our goals for 2011 include the continued advancement towards approval of QNEXA in the US and the EU and filing the NDA for avanafil."
Fourth Quarter ResultsIn November 2010, we sold MUSE and the related assets. Accordingly, all historical financialPage: 1 2 3 4 5 6 7 Related medicine technology :1
. Results From Phase 3 EQUATE Trial of VIVUS Qnexa Highlighted at European Congress on Obesity2
. VIVUS Initiates Open Label Safety Study of Avanafil for Erectile Dysfunction3
. Data on VIVUS Qnexa to be Featured at European Association for the Study of Diabetes Annual Meeting4
. VIVUS Announces Promotion of Peter Tam to President5
. VIVUS to Present at Lazard Capital Markets Healthcare Conference6
. VIVUS Submits Qnexa(R) New Drug Application to the FDA for the Treatment of Obesity7
. VIVUS to Host Conference Call and Webcast Discussion of Avanafil Phase 3 Results8
. VIVUS Announces Sale of MUSE Assets to Meda9
. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®10
. VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results11
. VIVUS to Present at Two Upcoming Investor Conferences