Sumavel DosePro and Levadex to earn up to $400M by 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Zogenix/Astellas Pharma/Desitin Pharmaceuticals' needle-free Sumavel DosePro, which launched earlier this month in the United States, and MAP Pharmaceuticals' orally-inhaled Levadex will earn approximately $400 million in combined sales by 2018 in the migraine drug market.

The Pharmacor 2010 finding from the topic entitled Migraine reveals that fast-acting reformulations of proven therapies such as Sumavel DosePro and Levadex will offer new and useful treatment alternatives for migraine patients who receive inadequate relief from other therapies (such as oral triptans), migraineurs who suffer nausea and vomiting and others with specific treatment needs. However, high cost, reimbursement challenges and widespread patient preference for oral pills are expected to limit the use of these unique drug-device combinations to only a small share of migraine patients.

Earlier this month, MAP Pharmaceuticals announced that the U.S. Food and Drug Administration would not require the company to conduct a second, confirmatory Phase III efficacy study for Levadex in the acute treatment of migraine. This decision was based on strong clinical trial results seen in the first pivotal study for Levadex and was likely further supported by the agent's well-established efficacy and safety profile for the acute treatment of migraine in several formulations currently available.

"This announcement showcases the advantages in clinical development enjoyed by companies that develop novel reformulations of proven medicines," said Decision Resources Analyst Jonathan Searles. "Previously, Zogenix was able to expedite development of its needle-free sumatriptan injectable, Sumavel DosePro, by leveraging the well-established clinical data for subcutaneous sumatriptan. However, MAP Pharmaceuticals must still conduct a long-term safety extension study of Levadex to assess a number of factors that include the pulmonary and cardiovascular safety of this novel formulation."

The Pharmacor 2010 findings also reveal that the recent discontinuation of Addex Pharmaceuticals' ADX-10059 for the prophylactic treatment of migraine underscores the risks and uncertainty involved in transitioning a novel migraine therapy that has demonstrated early promise in acute migraine studies into a daily prophylactic regimen. In 2009, similar safety concerns in a Phase II preventive clinical trial prompted the discontinuation of Merck's telcagepant for migraine prophylaxis and delayed regulatory filings for the agent for its lead indications as an acute migraine treatment.