Med Check: Rapid Blood Test for Concussion; REMS for Some Fentanyl Products; Phase 3 for Troriluzole for OCD; Remote Neuromodulation Device for Adolescent Migraine

FDA Approves Rapid Blood Test for Concussions

In January the FDA approved Abbott’s i-STAT Alinity handheld device for detecting mild traumatic brain injury (TBI), the company announced. Test results are available within 15 minutes using plasma that is placed into a test cartridge. The test was developed in collaboration with the U.S. Department of Defense.

The test measures glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase L1 in blood plasma—two biomarkers that indicate brain injury when they are elevated. According to a statement by the company, the device provides test results with 95.8% sensitivity and greater than 99% negative predictive value. A negative test can rule out the need for a CT scan, and having a blood test available could reduce the number of unnecessary CT scans, according to the company.

FDA Toughens REMS for Some Fentanyl Products

In December the Food and Drug Administration (FDA) took steps to strengthen the Risk Evaluation and Mitigation Strategy (REMS) program for transmucosal immediate-release fentanyl (TIRF).

“To use the TIRF medicines safely, these patients must be opioid tolerant based on concurrent regular use of another opioid medication,” the FDA wrote in a statement. “Despite the decline in the use of TIRF medicines in recent years, data have suggested that prescribing of TIRF medicines still occurs in patients who are not opioid tolerant. With this in mind, the FDA finalized modifications to the REMS program to address the persistence of these concerning prescribing practices.”

The TIRF REMS program now requires the following:

• Prescribers must document a patient’s opioid tolerance with each prescription of a TIRF medicine for outpatient use.

• Outpatient pharmacies dispensing TIRF medicines must document and verify a patient’s opioid tolerance before dispensing.

• Inpatient pharmacies must develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized.

• A new patient registry will monitor for accidental exposure, misuse, abuse, addiction, and overdose.

Phase 3 Trial Enrollment Begins for Troriluzole for OCD

Biohaven has begun enrollment for a phase 3 trial to assess the efficacy and safety of 280 mg troriluzole once per day in patients with obsessive-compulsive disorder (OCD), the company announced in January. The trial will include two double-blind, placebo-controlled studies with approximately 600 patients in each. Troriluzole normalizes synaptic levels of glutamate, a key neurotransmitter implicated in OCD.

Biohaven is pressing forward with the phase 3 trial even though troriluzole did not meet its primary endpoint in a previous trial, wherein scores on the Yale-Brown Obsessive-Compulsive Scale for patients who took troriluzole were not statistically significantly better than those who took placebo after 12 weeks. In the previous trial, scores in patients who took troriluzole dropped an average of 5.9 points from baseline, compared with 4.9 points in those who took placebo. However, after eight weeks, there was a 1.5-point gap in scores between the troriluzole group and the placebo group.

Remote Neuromodulation Device Shows Promise For Adolescent Migraine

A study in Headache suggests that Nerivio, a wearable device approved for treating migraine in adults, may also be helpful in treating the condition in adolescents, manufacturer Theranica announced in December. The device, which is worn with an arm band and controlled through an app on the patient’s smartphone, uses remote electrical neuromodulation to activate the body’s natural ability to modulate pain.

Researchers evaluated 45 patients aged 12 to 17 with a history of episodic and chronic migraines who completed at least one treatment with Nerivio. Over the course of the 12-week study, the device treated 159 migraine headaches, 49% of which were moderate and 33% of which were severe at baseline. Two hours after treatment, 71% of participants reported pain relief and 35% reported being free of pain, results that were sustained for 24 hours in 90% of cases. At two hours, 69% of patients experienced improved functional ability, which was defined as the ability to do schoolwork and perform “usual activities.” There were no device-related serious adverse events. ■