Weekend ICYMI: September 2 to September 6

FDA Clears First Digital Therapeutic for Treatment of Generalized Anxiety Disorder

The FDA has granted clearance to the digital therapeutic DaylightRX for the treatment of generalized anxiety disorder (GAD) as an adjunct to usual care in patients aged 22 years and older, Big Health announced in a release. The therapy is the first digital treatment approved to treat GAD in the United States. DaylightRX is a digital formulation of cognitive behavioral therapy and includes lessons that teach patients different evidence-based techniques to help reduce chronic worry and anxiety, including applied relaxation, stimulus control, cognitive restructuring, and exposure therapy.

Community Pharmacist-Led Intervention for Victims of Domestic Abuse, Suicidal Ideation

With a plethora of barriers preventing individuals from receiving assistance for domestic abuse and suicidal ideation, researchers found that a community pharmacy-based intervention can weaken those barriers and offer a safe option for patients seeking help. In what authors of the study call “lifeguard pharmacy” services, participants found satisfaction within a pharmacy-based intervention because of its ability to offer hope, accessibility, and discretion.

NCPA Calls on CMS to Establish PBM Protection for Independent Pharmacies

With Medicare open enrollment fast approaching for the 2025 plan year, the National Community Pharmacists Association (NCPA) addressed the Centers for Medicare & Medicaid Services (CMS), urging them to create guardrails for independent pharmacies to stay protected against predatory pharmacy benefit manager (PBM) contracts. With Medicare Part D plans constituting a significant portion of community pharmacies’ businesses, NCPA prompted CMS to establish fair protections for the upcoming year, preventing PBMs from locking independent pharmacies into unfair, long-lasting contracts.

C Difficile Treatment Shows Positive Results in Phase 2 Study

Positive results have been announced from a phase 2 trial evaluating the safety and efficacy of CRS3123 in adult patients with a primary episode or a first recurrence of clostridioides difficile infection, biopharmaceutical company Crestone announced in a release. Data from the phase 2 trial (NCT04781387) showed that CRS3123 met its primary endpoint of rate of clinical cure at test of cure in the intention to treat group.

After Initial Stumbles, Tolebrutinib Achieves Primary Endpoint in Phase 3 nrSPMS Trial

Tolebrutinib has successfully met its primary endpoint of improvement over placebo in delaying time to onset of confirmed disability progression in patients with non-relapsing secondary progressive multiple sclerosis in the HERCULES phase 3 clinical trial. It has become the first and only study to achieve this clinical effect in the patient population, according to a Sanofi news release. Previously, tolebrutinib missed the mark in the randomized, double-blind, phase 3 clinical studies GEMINI 1 (NCT04410978) and GEMINI 2 (NCT0441099).

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