Altamira announces FDA clearance of IND for AM-125

Altamira Therapeutics announced that the U.S. Food and Drug Administration has completed its safety review of the Company’s Investigational New Drug application for AM-125 in acute vestibular syndrome.. The FDA concluded that the proposed Phase 2 clinical trial with AM-125 in the treatment of posterior canal benign paroxysmal positional vertigo, the most common type of vertigo, may proceed. BPPV is characterized by repeated episodes of vertigo produced by changes in the head position relative to gravity, e.g. when tipping the head backward. Patients suffering from BPPV experience significant inconveniences and disabilities during symptomatic episodes, as they interfere with day-to-day activities such as driving a car or climbing stairs. BPPV generally emerges in the elderly with a peak onset in the 5th and 6th decade. BPPV is typically caused by dislodged inner ear particles in one of the semicircular canals, most often the posterior canal. The debris elicits unwanted vestibular stimulation and may be cleared through physical repositioning procedures such as the Epley maneuver. Since a patient may experience dizziness and instability for some time even after a successful repositioning maneuver, betahistine as an antivertigo drug is frequently administered to help accelerate resolution. A recently published meta-analysis of several randomized controlled trials revealed that Epley’s maneuver plus betahistine resulted in a significantly greater reduction in dizziness handicap compared to Epley’s maneuver alone. Unlike most countries in the world, where betahistine formulated as a tablet is the standard of care treatment for vertigo, betahistine is not approved for marketing in the United States. Altamira has been developing AM-125 in a nasal spray formulation which allows for significantly higher bioavailability than oral intake of betahistine.