Qsymia Regulatory Timeline

By skyeblue

  • Vivus submits NDA to the FDA for Qnexa

    After several promising rounds of clinical trials, Vivus submits a New Drug Application for obesity medication Qnexa to the FDA.

  • NDA accepted

    The FDA accepts Vivus' filing for approval for the drug; target review date is scheduled for Oct. 28, 2010.

  • Agency staffers report Qnexa concerns

    Panelists at the FDA question the ingredients; Qnexa is a combination of phentermine and the anticonvulsant topiramate, which at high doses has been linked to fetal malefactions.

  • FDA panel reviews Qnexa

    The FDA's panel for Qnexa recommended against approval due to the need for more information. Many panelists had reservations about the lack of long-term clinical data, especially in reproductive risks.

  • Optimistic long-term clinical data for Qnexa

    Vivus released results of a 108-week trial, reporting sustained weight loss of more than 10% for two years. Though researchers reported no known safety issues, the panel’s elusive concerns leave analysts confused about how to quell the experts' worries.

  • Vivus receives a CRL to the initial Qnexa NDA

    The FDA released a Complete Response Letter to Vivus requesting a detailed plan and more data on risks for women who are or may become pregnant to address concerns for Qnexa ingredient topiramate, which has been linked to fetal malefactions. Vivus' Release

  • FDA asks Vivus for birth defects data

    In an End-of-Review meeting with the FDA, Vivus was asked to assess oral cleft risks in offspring of women treated with Qnexa ingredient topiramate. More

  • Vivus releases fresh batch of obesity data

    Another long-term clinical trial showed positive weight loss trends, overall decrease in blood-pressure, and reduced antihypertension medication. Release

  • Vivus reports an agreement with the FDA

    Vivus discussed plans to resubmit Qnexa for approval as restricted to obese men and women past childbearing years, satisfying the agency's concern. Report

  • Vivus resubmits Qnexa to the FDA

    Vivus resubmits Qnexa to the FDA with a warning to women capable of having children along with a risk-evaluation and mitigation study to lessen panelists' concerns. More

  • Hopes for Qnexa approval fall after birth defects data

    Clinical data in a Vivus study further promote claims that topiramate is connected to oral cleft in utero, hurting Qnexa's chances at unrestricted FDA approval. Vivus' release

  • Vivus' Qnexa regulatory update; FDA willing to drop restriction

    The FDA helps Vivus around the regulatory brick wall by dropping restriction on women with child-rearing potential. More

  • FDA notes concerns about Vivus diet pill’s safety

    Despite Vivus' new safety study, the FDA issues heart rate and pregnancy concerns ahead of panel review.

  • Non-agency gives strong support to Qnexa

    The Endocrinologic and Metabolic Drugs Advisory Committee determines that Qnexa warrants approval with rewards outweighing risks.

  • FDA panel favors cardio studies for risky weight drugs

    The FDA panel drafts a proposal suggesting the addition of cardio safety studies to the obesity drugs, including those that have no indication of heart risk, further complicating chances of Qnexa's approval. Story

  • FDA delays decision on Qnexa

    In light of the high-risk nature of obesity medication, the FDA delays a decision on Qnexa for more time to assess Vivus' risk evaluation plan. Report

  • FDA approval

    Qnexa receives one of the first FDA nods for an obesity drug in 13 years under the new brand name Qsymia. News