Company submits application to FDA for alcoholism abuse drug

Orexo AB, a Swedish pharmaceutical company, recently submitted an application to the U.S. Food and Drug Administration (FDA) for its treatment of bothersome or harmful alcohol consumption, including alcohol use disorder (AUD).

Approximately 16.6 million people in the United States suffer from heavy alcohol use, and annually there are more than 88,000 deaths related to its use.

GAIA, a global digital therapeutics company, sells the drug, vorvida, in Switzerland and Germany. Orexo expects the FDA will hold a hearing during the second quarter of the year, after which commercialization of the drug can occur in the United States.

“Based on our deep understanding of treating addiction disorders, we are acutely aware of the need for better access to quality treatment options for all patients,” Orexo CEO and president Nikolaj Sørensen said. “We also recognize that the treatment of substance use disorder, such as alcohol, requires a multifaceted approach, often including both medication and psycho-social support. Access to vorvida will enable patients to treat heavy alcohol use in their homes, when they need it the most. This ease of use, combined with the strong clinical evidence, suggests vorvida could present an important treatment option for patients.”

Orexo acquired the U.S. commercialization rights from GAIA in November.