Program delivered on smartphone is based on core principles of cognitive behavioral therapy, with focus on behavioral activation

Trial results demonstrate clinically meaningful reduction in depression symptoms

Completing SparkRx as recommended results in statistically significant reduction in symptoms compared to control

SAN FRANCISCO–(BUSINESS WIRE)–Today, Limbix, a prescription digital therapeutic company developing mental health treatments for adolescents, announced the launch of SparkRx, the first evidence-based digital therapeutic for teens and young adults experiencing symptoms of depression.

SparkRx is rooted in cognitive behavioral therapy, a therapeutic modality proven to assist with the symptoms of depression and other mental health disorders. SparkRx is an adjunct treatment for teens and young adults aged 13-22 who are experiencing symptoms of depression. More safety information can be found on the SparkRx website. SparkRx is accessible via a health care provider and available at no cost to patients for a limited time. Providers interested in offering SparkRx can sign up on the SparkRx website and receive a unique access code to give to patients. The access code will allow patients to use the app.

SparkRx meets young people in a comfortable format – their smartphone – allowing them to take control of their treatment and make progress at their own pace, over a 5-7 week period. SparkRx teaches teens and young adults to better understand their depression, helping them practice skills like mood tracking, behavioral activation, problem solving and mindfulness. The program also features a supportive robot guide named Limbot. Alongside Limbot, adolescents with symptoms of depression can use SparkRx to learn about the relationship between mood and behavior, to identify and engage in activities that align with their values, and to celebrate their achievements along the way. Limbix’s interdisciplinary team designed SparkRx alongside subject matter experts in adolescent psychology.

“Today’s youth are experiencing unprecedented mental health challenges. There is a shortage of timely treatment options to get them the help they need, when they need it the most,” said Benjamin Alouf, M.D., chief medical officer at Limbix. “SparkRx provides an immediate, safe, self-guided, and private treatment option for teens and young adults. I’m hopeful that SparkRx can help teens as well as pediatricians, family practitioners, therapists, school counselors— anyone serving as a first line of defense for teens who need mental health care.”

At launch, patients between the ages of 13 and 22 will be eligible to use SparkRx under the U.S. Food and Drug Administration’s (FDA) Enforcement Policy for Digital Health Devices Treating Psychiatric Disorders During the COVID-19 Public Health Emergency. Health care providers interested in offering SparkRx to their patients should register at https://www.sparkrx.com/.

SparkRx has not been cleared or approved by the FDA, nor have these trial results been validated by the FDA with regard to the safety or efficacy of SparkRx. Limbix intends to pursue full FDA regulatory review of SparkRx. The company is working with payers to establish reimbursement to ensure SparkRx is as accessible to patients as possible should it receive FDA clearance. Patient financial support programs will also be made available for those who qualify.

In a separate announcement today, Limbix presented positive results from a clinical trial of SparkRx at the American Academy of Pediatrics National Conference & Exhibition Virtual Experience.

For participants that completed the program as recommended (n = 83), SparkRx led to a statistically significant reduction in depression symptoms compared to an active control app (p = 0.023) and a 21% remission rate compared to a 4% remission rate for control at the end of treatment. Treatment response rates were 29% and 16%, respectively, for SparkRx and control.

Across the full study sample of 121 participants with moderate to severe depressive symptoms, adolescents randomized to SparkRx showed a clinically meaningful reduction in depression symptoms. At the end of the study, 24% of SparkRx participants had a treatment response and 17% were in remission. The intention-to-treat analysis comparing SparkRx to control was not significant (p = 0.076).

“The results of our clinical trial are promising and underscore the potential in designing scientific programs that providers can leverage to treat adolescents with symptoms of depression,” said Jessica Lake, PhD., chief science officer at Limbix. “Our clinical trial provides us valuable insights which will allow Limbix to continue to pursue regulatory pathways to FDA clearance.”

About SparkRx

Limbix SparkRx is a cognitive behavioral therapy-based digital therapeutic program for teens and young adults experiencing symptoms of depression. SparkRx provides clinicians with an immediate, safe and private adjunct treatment option to offer their patients. SparkRx, which was made to be completed over the course of multiple weeks, aims to overcome common barriers to mental health care accessibility and meet young people in a comfortable format – their smartphone. The self-guided program teaches skills like mood tracking, behavioral activation, problem solving and mindfulness. Limbix’s interdisciplinary team designed SparkRx alongside subject matter experts in adolescent psychology with the scientific rigor, clinical expertise and digital innovation needed to set it apart in the field.

For more information about SparkRx or to register to offer SparkRx to patients, please visit https://www.SparkRx.com/.

Summary of Important Safety Information:

SparkRx is a digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy – Behavioral Activation) in patients 13 to 22 years of age as adjunct treatment for symptoms of depression.

  • SparkRx is not meant to be used as treatment without supervision of a health care provider.
  • SparkRx is not meant to be a substitution for any treatment or medication.
  • SparkRx does not address concerns of active suicidal ideation with intent.
  • SparkRx is not intended for the prevention of suicide attempts or self-harm behaviors.

See instructions for use at SparkRx.com for complete safety & use information.

About Limbix

Limbix is a prescription digital therapeutic company passionate about creating mental health treatments for adolescents. The Limbix team is uniquely suited to develop prescription digital therapeutics, as its diverse team of clinicians, product designers, researchers, and engineers understand the value of pairing clinical expertise with technological innovation. Their first digital therapeutic, Limbix SparkRx, is now available for licensed health care professionals to offer to patients nationwide.

For more information about Limbix please visit https://www.limbix.com.

Social Media:

https://twitter.com/LimbixHealth
https://www.linkedin.com/company/limbix-health/
https://www.facebook.com/limbix.inc

Contacts

Liz Boten

Canale Communications

Liz.boten@canalecomm.com
720.219.5107