label
two people using a tablet

Demonstrated effectiveness and safety

PDTs have been proven effective for a range of behavioral health conditions, including ADHD, anxiety, depression, insomnia, PTSD, and substance use, and are being studied in other mental health conditions.1,4,5 Because PDTs are delivered digitally, people treated with them are less likely to experience adverse events or drug interactions.2,4

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PDTs are rigorously studied for safety and effectiveness in randomized clinical trials.1

PDTs are designed to be convenient and user friendly.1

Patients can be prescribed PDTs within the physician’s office. Patients may then download the PDT and are guided through the activation steps.6

People living with mental health conditions can discreetly access validated therapeutic techniques delivered by PDTs anyplace, anytime on smartphones or tablets.1,3,7,8

While drugs are “approved” by the FDA, PDTs are FDA “authorized” or cleared as a software as a medical device (SaMD). All of them are required to have clinical trials as part of the FDA authorization.9

Expand accessibility to evidence-based treatments for certain disease states

PDTs can work in concert with remote education, assessment, and telehealth visits to further enable a holistic approach to care.6

man and woman looking at a tablet together

PDTs can be incorporated into a multimodal approach1,2

Independent of Other Therapy Icon
Independent

Individual, and in some cases, independent of other therapies. Can also be used at the same time as other treatments.1,2 

Concomitant With Pharmacological Intervention Icon
Adjunct

Concomitant with pharmacological intervention.1,2

Pharmacological & Non-pharmacological Combined Icon
Combined

Works in combination with pharmacological and nonpharmacological interventions by complementing self-management of conditions and related healthcare factors.1,2

PDTs meet higher clinical and regulatory benchmarks than health and wellness apps1,2

PDTs Meet Higher Clinical & Regulatory Benchmarks vs Health & Wellness Apps
PDTs Meet Higher Clinical & Regulatory Benchmarks vs Health & Wellness Apps
Survey Statistics From 2,000 People

PDTs may connect patients with innovative digital modalities that they agree are beneficial6,12

HCPs Staying Connected With Patients

PDTs can help healthcare professionals make timely, informed, ​and accurate clinical diagnoses and patient care decisions6,7

Empower your patients to take an active role in their mental health

See how

References

  1. Brezing CA, Brixner DI. The rise of prescription digital therapeutics in behavioral health. Adv Ther. 2022;39(12):5301-5306. doi:10.1007/s12325-022-02320-0

  2. Liesch J, Murphy D. Digital Therapeutics 101: An Introduction and Overview. Blue Matter Consulting. Published 2021. Accessed May 17, 2024. https://bluematterconsulting.com/wp-content/uploads/2021/06/Digital-Therapeutics-101-eBook-06-2021.pdf

  3. Maricich YA, Gerwien R, Kuo A, Malone DC, Velez FF. Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder. Hosp Pract (1995). 2021;49(5):348-355. doi:10.1080/21548331.2021.1974243 

  4. Wang C, Lee C, Shin H. Digital therapeutics from bench to bedside. NPJ Digit Med. 2023;6(1):38. doi:10.1038/s41746-023-00777-z

  5. Jacobson NC, Kowatch T, Marsch LA, eds. Digital Therapeutics for Mental Health and Addiction: The State of the Science and Vision for the Future. Academic Press; 2023.

  6. Shafai G, Aungst TD. Prescription digital therapeutics: a new frontier for pharmacists and the future of treatment. J Am Pharm Assoc (2003). 2023;63(4):1030-1034. doi:10.1016/j.japh.2023.03.012 

  7. Dang A, Arora D, Rane P. Role of digital therapeutics and the changing future of healthcare. J Family Med Prim Care. 2020;9(5):2207-2213. doi:10.4103/jfmpc.jfmpc_105_20

  8. Maricich YA, Xiong X, Gerwien R, et al. Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. Curr Med Res Opin. 2021;37(2):175-183. doi:10.1080/03007995.2020.1846023 

  9. Watson A, Chapman R, Shafai G, Maricich YA. FDA regulations and prescription digital therapeutics: evolving with the technologies they regulate. Front Digit Health. 2023;5:1086219. doi:10.3389/fdgth.2023.1086219

  10. EndeavorOTC. Digital Therapeutics Alliance. Accessed October 7, 2024. https://dtxalliance.org/products/endeavorotc/

  11. gameChange. Digital Therapeutics Alliance. Accessed October 7, 2024. https://dtxalliance.org/products/gamechange/

  12. Furstenau D, Gersch M, Schreiter S. Digital therapeutics (DTx). Bus Inf Syst Eng. 2023;65:349-360. doi:10.1007/s12599-023-00804-z