When administered along with the Epley maneuver, a canal repositioning procedure, oral betahistine showed efficacy in the treatment of posterior canal benign paroxysmal positional vertigo (BPPV). The histamine analogue reduced dizziness when administered with Epley’s maneuver in a meta-analysis study.

The meta-analysis looked at nine randomised control trials with 860 posterior canal BPPV patients – 432 of which were treated with Epley’s maneuver plus betahistine and 428 solely with Epley’s maneuver.

Compared to those who received the canal repositioning procedure, patients administered with betahistine showed a greater reduction in dizziness handicap (as measured by the Dizziness Handicap Inventory (DHI)).

Betahistine’s efficacy history is cloudy. Numerous reviews have demonstrated contrasting data on how successful the drug is in reducing symptoms, such as vertigo, in patients with Ménière’s disease.

The meta-analysis validation on betahistine’s clinical use for vertigo is welcomed by Altamira Therapeutics which has been developing AM-125 – a patented formulation of betahistine for intranasal administration, for the treatment of acute vestibular syndrome (AVS). AM-125 is administered intranasally which achieves higher bioavailability of betahistine compared to oral administration.

Altamira, headquartered in Zug, Switzerland, plan to file an investigational new drug (IND) application for AM-125, which has been successfully tested in a Phase II clinical trial, in May 2023.

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“We are pleased to see betahistine’s clinical utility further confirmed in this meta-analysis of several studies in BPPV patients,” said Thomas Meyer, Ph.D., Altamira’s founder, chairman and CEO.

“We feel vindicated in our choice of BPPV to advance the clinical development program for AM-125. Where marketed, BPPV has traditionally been one of the most frequent indications for oral betahistine. We look forward to submitting the IND application shortly which will be an important milestone on our way to transfer the innovative AM-125 program to one or several partners as we are repositioning the Company around our RNA delivery technology,” Meyer added.