Orexo eyes launch of digital therapy for heavy drinkers this year


Orexo has submitted its Vorvida digital therapy for the treatment of heavy drinking for approval by the FDA, setting up a possible launch in the second half of this year.

The Swedish drugmaker – best known as a developer of opioid addiction therapies – licensed US rights to Vorvida from its developer Gaia AG last year. Vorvida is already being rolled out in European markets including Germany and Switzerland.

Orexo is seeking approval of the digital therapeutic for the treatment of bothersome or harmful alcohol consumption, including diagnosed alcohol use disorder (AUD).

It combines cognitive behavioural therapy coupled with machine learning and is designed to guide heavy drinkers through a series of steps to reach the target of reduced alcohol intake.

In a commentary on the filing, Edison analyst Nathanial Calloway says the marketing application is interesting because the regulatory pathway for digital therapeutics in the US is in a state of flux.

“There is no well-defined pathway for devices like Vorvida, but instead the FDA decides whether it should be subject to review on a case-by-case basis depending on the risk to human health,” he points out in a research note.

“The current application submitted by the company is through a 513(g) request in which it is seeking feedback on how it will be classified, and a response is expected in the statutory 60 days.”

Vorvida was studied in 2015 in a 608-patient controlled trial in Germany, which showed a significant reduction in alcohol consumed per day and binge drinking days per month at both three and six months, with statistically-significant improvements across the board.

Calloway reckons that the clinical data notwithstanding, digital therapies face “significant hurdles” in the marketplace and there are no clear success stories for behavioural health products like Vorvida.

“Given that drinking is a significant drain on health resources, we can envision a scenario in which it is marketed to payors to reduce costs,” he suggests.

Orexo says that heavy alcohol use is a major health crisis affecting approximately 16.6 million people in the US, killing more than 88,000 a year, and costing the country around $249 billion annually.

The company has started to build its commercial team for Vorvida, but isn’t talking about its specific plans just yet, including the pricing of the therapy if approved. It is expected to provide more information on its strategy at an investor update in Stockholm on 17 March.

“Access to Vorvida will enable patients to treat heavy alcohol use in their homes, when they need it the most,” says Orexo’s chief executive Nikolaj Sørensen.

“This ease of use combined with the strong clinical evidence, suggests Vorvida could present an important treatment option for patients.”