Rejoyn™: First FDA-Cleared Digital Therapeutic for MDD Symptoms Launches

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Key Highlights

  • Rejoyn™ cleared by FDA in March 2024 for treating major depressive disorder (MDD) symptoms.
  • Available via prescription, Rejoyn™ offers a fully digital pathway from consultation to therapy access.
  • Introductory pricing at $50 for patients, with broader insurance coverage expected soon.
  • Rejoyn’s neuroplasticity-based exercises and CBT lessons aim to reduce MDD symptoms.
  • No side effects or drug interactions identified in pivotal clinical trials.

Source: Business Wire

Notable Quotes

  • “We’re excited that MDD patients and their healthcare providers now have a new treatment option that works alongside medication – with no related side effects or drug-interaction concerns.” — John Kraus, M.D., Ph.D., EVP & CMO at Otsuka Pharmaceutical Development & Commercialization
  • “This milestone has been over five years in the making and reflects the dedication, care, and evidence-based rigor with which we are developing digital treatments before putting them in the hands of patients.” — Sanket Shah, President at Otsuka Precision Health

SoHC's Take

The launch of Rejoyn™ marks a significant advancement in the treatment of MDD, offering patients a new, accessible option that integrates seamlessly with existing therapies. By leveraging neuroplasticity and CBT, Rejoyn™ could set a new standard in digital therapeutics, especially as it navigates the complexities of mental health treatment without adding the burden of side effects. As insurance coverage expands, Rejoyn™ has the potential to become a mainstream adjunctive treatment, benefiting a broad population of patients struggling with depression.

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