Second Pivotal Efficacy Study For Levadex Not Required, Says FDA

In May 2009, the company had announced that the efficacy portion of its Phase 3 Freedom-301 clinical study of Levadex met all four primary endpoints. The company had previously anticipated initiating a second pivotal efficacy study in the first quarter of 2010.

The remaining clinical studies include the ongoing 12 month open-label safety extension of the Freedom-301 study, a pharmacokinetic (PK) study and a pharmacodynamic (PD) study. The company anticipates that patients in these studies will complete treatment in 2010.

Reportedly, the goal of the long-term safety extension is to evaluate overall safety, including pulmonary and cardiovascular safety, of Levadex in 300 patients for six months and 150 patients, including asthmatics, for 12 months.

The study is being conducted under a Special Protocol Assessment with the FDA. As previously announced, as of October 2009, more than 400 patients had completed at least six months of treatment and over 7,800 headaches had been treated, with no drug-related serious adverse events reported.

Timothy Nelson, president and CEO of MAP, said: “We are pleased that the Levadex program can move forward without a second pivotal efficacy study; this news underscores our confidence in the program and allows us to focus our resources and efforts on completing our remaining clinical studies to support our NDA submission.

“We believe that Levadex has the potential to provide rapid and sustained relief of migraine symptoms to many of the approximately 30 million migraine sufferers in the US, including many who are not helped by currently available migraine therapies and we are committed to rapidly moving this program forward.”