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FDA Fast Tracks Investigational Nonopioid Treatment for Acute Pain

The Food and Drug Administration (FDA) has granted Fast Track designation to LTG-001 (Latigo Biotherapeutics, Inc.) for the treatment of acute pain.

LTG-001, an oral Nav1.8 selective inhibitor, works by blocking peripheral sensory neurons responsible for pain signaling. The Fast Track designation is supported by data from a phase 1 trial (ClinicalTrials.gov Identifier: NCT06049095) that evaluated the safety, tolerability, relative bioavailability, and food effects of oral LTG-001 in healthy study participants.

Results showed LTG-001 demonstrated rapid absorption (Tmax ~1.5 hours), suggesting the investigational therapy may provide quick pain relief. Predictable pharmacokinetics and proportional exposure were observed across the dose ranges.

“We are pleased the FDA has granted Fast Track designation to LTG-001, recognizing its potential to transform the treatment landscape for acute pain by targeting pain at its source,” said Nima Farzan, chief executive officer of Latigo. “This marks an important milestone for Latigo and reinforces the promise of LTG-001 as a highly selective, well-tolerated non-opioid approach for treating pain.”

The FDA’s Fast Track designation helps to accelerate the development and review of products for serious and life-threatening conditions where no treatment exists or where the investigational therapy is likely to provide an advantage over currently available treatments.

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