Date: 2017-02-03
Type of
information: Initiation of development program
phase:
Announcement: initiation of development program
Company: Auris Medical (Switzerland)
Product: AM-125 (betahistine dihydrochloride)
Action
mechanism:
- Betahistine is a small molecule drug that acts as a partial histamine H1-receptor agonist and a H3-receptor antagonist. The compound has demonstrated increased cochlear, vestibular and cerebral blood flow, vestibular compensation and the ability to inhibit neuronal firing in the vestibular nuclei. Oral betahistine is approved for the treatment of Meniere's disease and vestibular vertigo and marketed in more than 80 countries worldwide. Since its launch, more than 130 million patients have been prescribed betahistine. However, betahistine has not been approved for marketing in the United States for the past few decades.
Disease: Meniere's disease, vestibular vertigo
Therapeutic
area: Otorhinolaryngology
Country:
Trial
details:
Latest
news:
- • On February 3, 2017, Auris Medical announced that it has added a third clinical-stage development program to its pipeline and is expanding into the field of vestibular disorders. Under the product code AM-125, the Company will develop betahistine dihydrochloride in a spray formulation for the intranasal treatment of Meniere's disease and vestibular vertigo. Auris Medical has entered into an agreement with Otifex Therapeutics to purchase various assets related to intranasal betahistine, including preclinical and clinical data as well as certain intellectual property rights. In a Phase 1 trial conducted by Otifex, intranasal betahistine showed good tolerance and a significantly higher bioavailability than reported for oral betahistine administration. Auris Medical plans to initiate a second Phase 1 trial in 2017.
Is
general: Yes
