Novartis app for opium addicts gets US approval

The reSET-O prescription medical application is a 12-week software application providing cognitive behavioral therapy as a support to outpatient treatment. Keystone

Sandoz Inc., a division of Swiss pharmaceutical giant Novartis, and US company Pear Therapeutics announced this week that the the U.S. Food and Drug Administration (FDA) has approved an app that can be prescribed to help treat opium addicts.

For patients 18 years or older who are currently under the supervision of a clinician, reSET-O is indicated as a prescription-only mobile medical application, Novartis noted in a media statementExternal link. 

As a digital therapist, the app is intended to protect patients from relapses with interactive dialogues.  Every day, approximately 115 Americans die after overdosing on opioids. 

“Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation and to help individuals finally take control of their own health in a meaningful way,” said Sandoz CEO Richard Francis. “New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes. At Sandoz, we are proud to be a joint pioneer in this exciting new field.”

The Novartis generics subsidiary SandozExternal link is responsible for marketing the application prescribed by the physician. In the spring, Sandoz signed a cooperation agreement with Pear TherapeuticsExternal link. Sandoz says it hopes to be able to charge $15 (CHF15) per month for the app. However, the price is not yet definite, the NZZ am Sonntag reported.External link

The US regulatory authority has been convinced by its success. Over 12 weeks, 170 patients participated in an opiate withdrawal program. All received a replacement drug. However, 82.4% of those who used the app remained in the program. In the group without a supportive app, only 68.4% managed the full three months, the FDA reported in a press release.

In the United States, 48.5 million people are addicted to drugs. About 18.5% of the adult population consume illegal drugs such as heroin or abuse legal substances such as painkillers. Alcoholics are not included in the figures.

The statistics also reflect the devastating opium dependence of broad sections of the population. The problem is widely blamed on the lax prescription practice of new, supposedly non-addictive painkillers since the 1990s. The “economic burden” of this epidemic amounts to $78.5 billion annually, according to the Centers for Disease Control and PreventionExternal link.