Drug‑Free Solution to Opioid Withdrawal

SOON FOR BABIES TOO? –

Feb. 18, 2021 – The Texas startup was founded in Houston in 2018, but is now headquartered in Dallas where it develops medical devices such as the system.

Spark received clearance from the FDA on January 5, 2021, for its Sparrow Therapy System, a wearable neurostimulation device for drug-free opioid withdrawal relief for adults.

Dr. Anjum Bux was the first in the U.S. to successfully treat commercial patients using the system, with his initial patient tapering from high-dose oral opioids in seven days with no reported withdrawal symptoms, according to a statement.

“The ability to safely taper patients’ opioid use over days instead of months while reliably managing withdrawal symptoms is a game-changer for my patients and practice,” Bux said in a statement. “This is an important advancement in the fight against opioid use disorder.”

“Easiest detox ever”

In the last year, the company conducted adult clinical trials with “great results,” Powell previously told Dallas Innovates. “We have high confidence in our solution; especially when we hear comments from our clinical trial participants saying, ‘Easiest detox ever.’”

In Spark’s clinical trials targeting patients with opioid use disorder, 89 percent of participants experienced mild to no withdrawal symptoms through 60 minutes of therapy and one in three had no symptoms after just the first day of treatment, according to a statement. In two days, 100 percent of the participants had a clinically meaningful reduction in opioid withdrawal symptoms.

“One of the biggest challenges for those recovering from long-term opioid use is the changes to the brain’s function that make it more difficult to handle stressors,” Powell says. “We believe our system can help the brain return to a state more like pre-opioid use and give patients the tools to stay sober in the long term.”

Spark saw a gap in care for the youngest victims of addiction—babies

The system is just one of the medical devices that the company has developed. Spark also has another device in clinical trials to help the youngest victims—babies. Powell says the team saw a critical gap in care and expanded its neurostimulation solution to cover Neonatal Opioid Withdrawal Syndrome (NOWS).

The startup previously said it would focus on the benefits of the neurostimulation device to help with long-term addiction recovery after the opioid withdrawal tool has been approved.