According to Auris Medical, the FDA has granted orphan drug designation to its intranasal betahistine for the treatment of obesity associated with Prader-Willi syndrome (PWS). The company also said that it has signed a letter of intent to in-license rights to US patents covering the use of betahistine for two other indications, depression and attention-deficit/hyperactivity disorder (ADHD).
Auris Medical Founder, Chairman, and CEO Thomas Meyer commented, “We are very excited to address additional neurological and metabolic disorders with our intranasal betahistine program. Histamine plays a key role in the regulation of a wide range of behavioral and physiological functions, including appetite, drinking, sleep, wakefulness, learning, attention and memory. Betahistine as a structural analog of histamine has been widely used outside the US for the treatment of vertigo for decades. It has also shown promising effects in preventing antipsychotic-induced weight gain, reducing excessive daytime sleepiness and improving cognitive function. While betahistine’s clinical utility has been limited by poor bioavailability when administered orally, our intranasal formulation allows for significantly higher plasma exposure, which is expected to translate into better therapeutic outcomes and open up new therapeutic uses.”
Earlier this year, Auris announced results from pre-clinical and Phase 1 studies showing significantly higher bioavailability for its intranasal formulation of betahistine compared to oral betahistine, and results from a second Phase 1 study were released in October 2018.
The company also announced in October that it had 2 studies planned for early 2019, a Phase 1 PK/PD study of AM-201 intranasal betahistine, which Auris is developing for the treatment of olanzapine-induced weight gain and a Phase 2 trial of AM-125 intranasal betahistine in patients with acute vertigo following vestibular schwannoma resection early in 2019.
Read the Auris Medical press release.
