Rx tech – Digital Pharma

Rx tech Newsletter — your source for the latest insights, product trends, and innovations driving Digital Transformation in the Pharmaceutical Industry.

1. FDA Clears First Digital Therapeutic for Generalized Anxiety Disorder

The FDA has cleared DaylightRX, the first digital therapeutic for treating generalized anxiety disorder (GAD) in adults aged 22 and older. Developed by Big Health, DaylightRX offers cognitive behavioral therapy (CBT) techniques, including relaxation, cognitive restructuring, and exposure therapy, via a smartphone app. This prescription-only digital therapy is designed to work alongside usual care. In clinical trials, DaylightRX demonstrated significant reductions in anxiety symptoms, with 71% of patients achieving GAD remission by week 10, compared to 33% in the control group. The therapy also improved symptoms of worry, depression, sleep, and quality of life, offering an accessible, non-medication treatment option for GAD patients.

2. Waltz Health Launches Specialty Pharmacy Platform, Partners with Reliance Rx

Waltz Health has introduced Waltz Connect, a platform aimed at cutting costs for specialty drugs, which drive 54% of the nation's drug expenses. Using AI, the platform routes prescriptions to the best pharmacy based on price and efficiency, helping insurers save 10% to 15% on specialty drugs. In partnership with Reliance Rx and over 80 other dispensing locations, Waltz Connect provides greater flexibility for payers. This new model aims to offer more transparency and cost savings compared to traditional pharmacy benefit managers.

3. Digital Therapeutics in Diabetes Show Potential for Improved Management

Recent studies suggest that digital therapeutics can improve various aspects of diabetes management, including physical activity, knowledge, self-management, mental wellbeing, and hemoglobin A1c (HbA1c) levels. Digital health tools, such as apps and games designed for diabetes care, are becoming an essential part of patient treatment plans, often used alongside medications.The study reviewed 23 digital games targeting both type 1 and type 2 diabetes across platforms like mobile phones and PCs. While some digital therapeutics significantly reduced HbA1c levels and improved diabetes knowledge, others showed benefits in physical activity, self-management, and mental health. Pharmacists are encouraged to stay informed about these tools, as they play a key role in patient care and outcomes when used in combination with traditional therapies.

4. Click Therapeutics' Digital Migraine Therapy Prepares for FDA Filing

Click Therapeutics' CT-132, a DTx for episodic migraine, achieved significant results in a late-stage trial, reducing monthly migraine days by approximately three — one more than the control group. The ReMMi-D trial involved 568 adults and is the first DTx for migraine to be evaluated using standards similar to drug therapies.

CT-132, intended to complement existing treatments, also improved patient quality of life and migraine disability scores. With these results, Click is preparing for an FDA submission, leveraging its breakthrough device status. If approved, CT-132 will provide a non-pharmacological treatment option for migraine sufferers. The success follows Click's prior FDA approval of its DTx for major depressive disorder, Rejoyn, and a breakthrough designation for a schizophrenia app.

5. Dexcom Launches Stelo Over-the-Counter CGM for Type 2 Diabetes

Dexcom has officially launched Stelo, its OTC continuous glucose monitor (CGM) designed for people with type 2 diabetes who do not use insulin. Available without a prescription, Stelo can be purchased online and offers users a 15-day wear sensor that provides glucose insights directly to their smartphones. It’s built on Dexcom’s G7 platform and offers a tailored experience for non-insulin users, making CGM more accessible for those without insurance coverage.

6. Pfizer Launches Direct-to-Consumer Platform PfizerForAll

Pfizer has unveiled PfizerForAll, a digital platform offering US patients access to same-day healthcare appointments, home delivery of medicines, and vaccination scheduling. The service includes telehealth visits for $35, alongside support for accessing 15 commonly prescribed Pfizer medicines and affordability programs. The platform initially covers COVID-19 and flu tests, Paxlovid treatments, and vaccines for COVID-19, flu, and RSV, with plans to expand services. Similar to Eli Lilly's LillyDirect, PfizerForAll aims to simplify healthcare by streamlining access to treatments and bypassing traditional middlemen.

7. Abbott Launches Lingo Over-the-Counter CGM in the U.S.

Abbott has launched Lingo, its new OTC continuous glucose monitor (CGM), now available in the U.S. and U.K. Designed for health-conscious consumers aged 18 and older, Lingo tracks glucose levels in real-time and provides personalized insights to help users manage their metabolism, diet, and overall wellness. Built on the FreeStyle Libre platform, Lingo offers non-diabetic users a way to monitor their glucose without needing a prescription. The system provides various purchasing options, with prices starting at $49 for a two-week "Learn" plan. Lingo aims to empower individuals to make informed lifestyle choices, contributing to better sleep, mood, and overall health.

8. Glytec and Roche Expand Diabetes Management Collaboration

Glytec has expanded its partnership with Roche to integrate its Glucommander insulin dosing software with Roche's Cobas Pulse blood glucose system. Initially launched in 2022, this collaboration addresses inpatient blood sugar management challenges. The expanded agreement now allows the use of Glytec's software with Cobas Pulse in both U.S. and global markets. By combining Roche's hardware with Glytec’s software, the collaboration enhances real-time glycemic management, improving patient care and streamlining workflows at the point of care.

9. Curio Raises Over $10M for Postpartum Depression App MamaLift Plus

Curio, a digital therapeutics (DTx) company, has raised over $10 million in Series A funding to support the launch of MamaLift Plus, an FDA-approved app designed to treat mild to moderate postpartum depression (PPD). The eight-week neurobehavioral intervention, approved under the FDA’s 510(k) regulatory route, is the first prescription DTx for PPD and will serve as an adjunct to clinician-managed outpatient care for women aged 22 and older. The app offers cognitive behavioral therapy (CBT) exercises, self-help tools, and trackers for sleep, mood, and activity.

The approval is based on the SuMMER trial, where 83% of women using MamaLift Plus showed a significant improvement in postpartum depression symptoms compared to 22% in the control group. Curio will also use the funds to expand its other DTx offerings, including FertiLift and MenoLift, aimed at fertility and menopause support, respectively.