February 9, 2020

FDA Approves Diazepam Nasal Spray and Fast Tracks New Drug for Spinal Cord Injury

FDA Approves Valtoco for Seizure Activity

The FDA has approved Valtoco® (diazepam nasal spray), a benzodiazepine for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern.

Seizure activity may present in injured worker populations that have experienced head injuries, including traumatic brain injury, which could require the prescribing of antiepileptic drugs.

Valtoco dosage is dependent on a patient’s weight and age. Dosage strengths include 5 mg, 7.5 mg, and 10 mg doses. Valtoco 5 mg and 10 mg doses are administered as a single spray intranasally into one nostril. Administration of 15 mg and 20 mg doses requires two nasal spray devices, one spray into each nostril.

According to the FDA-approved drug label, no more than two doses should be used to treat a single seizure episode, and Valtoco may be used to treat no more than one seizure episode every five days, and no more than five episodes per month.

Adverse reactions include somnolence (drowsiness), headache, and nasal discomfort. As a benzodiazepine, serious consideration should be taken if the patient is currently taking an opioid medication, as this drug-drug interaction caries serious risk.

FDA Fast Tracks Novel Therapy for Spinal Cord Injury

The FDA has granted Fast Track designation to AXER-204, a human fusion protein, for the potential treatment of chronic spinal cord injury.

AXER-204 is believed to stimulate the growth of never fibers, which could assist with the recovery of spinal cord injury. Phase 1 and 2 clinical trials are both currently underway. The Phase 1 trial is a multicenter, open-label, single ascending dose study in participants with chronic cervical spinal cord injury, involving four cohorts of six patients, each of whom will receive the same dose of AXER-204.

The Phase 2 trial is a multicenter, randomized, double-blind, placebo-controlled, repeat dose study in chronic cervical spinal cord injury. Up to 24 patients will randomly receive AXER-204 or placebo, with dose level and dose frequency dependent on outcomes from the Phase 1 trial.

By granting this medication a Fast Track designation, the FDA will increase communication with the drug developer and review portions of the NDA ahead of submission, giving this drug a leg-up in the approval process.

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