Auris Medical AG Reaches Special Protocol Assessment Agreement With FDA for Pivotal Phase III Clinical Trial With AM-101 in Treatment of Acute Peripheral Tinnitus
11/4/2013 9:40:11 AM
November 4, 2013 – Auris Medical today announced that it has reached agreement with the US Food and Drug Administration
(FDA) under a Special Protocol Assessment (SPA) for its pivotal phase III trial with the investigational product
AM-101 for the treatment of acute peripheral tinnitus. The SPA is an agreement between a trial sponsor
and the FDA regarding the design, endpoints and planned statistical analysis of the study to support a New
Drug Application (NDA).
The multi-centre, randomized, double-blind, placebo-controlled trial is designed to confirm the efficacy and
safety of AM-101 (Esketamine gel for intratympanic injection) in the treatment of acute peripheral tinnitus
following traumatic cochlear injury or otitis media. The TACTT21 study will enrol 330 patients aged 18 to 75
years at North American sites; all participants completing the study and continuing to meet certain criteria
will be eligible to enter an open label safety study (AMPACT12) and receive up to 3 treatment cycles with
AM-101 over up to 9 months.
In parallel, Auris Medical will initiate a second, similarly designed phase III trial (TACTT31) and open label
follow-on study (AMPACT22) in several European countries. The TACTT3 study will enrol 600 patients, of
which 300 during the acute stage (up to 3 months from tinnitus onset) and 300 during the post-acute
stage (4 to 12 months from tinnitus onset). Both TACTT studies are scheduled to start enrolment shortly.
“We appreciate the FDA’s input on the pivotal phase III study protocol and look forward to moving forward
with our AM-101 development programme”, commented Thomas Meyer, Auris Medical’s founder and Managing
Director. “Together with earlier feedback from a Scientific Advice procedure with the European Medicines
Agency this represents another important milestone on our way towards a safe and effective tinnitus
therapy”, he added.
About acute peripheral tinnitus
Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various
ear or other diseases. Inner ear tinnitus may be provoked by various injuries to the cochlea, the organ of
hearing, such as overexposure to noise or inflammation. It may be short and just transitory; however, it may
also become permanent. Tinnitus of less than three months of duration is considered acute, while older
tinnitus is considered chronic.
Inner ear tinnitus may be only a slight nuisance, but often it has a serious impact on the ability to sleep,
relax, or concentrate, or it may lead to tiredness, irritation, nervousness, despair, frustration, or even depression.
As of today, there exists neither a universal standard of care for acute inner ear tinnitus, nor a truly
proven, effective treatment method.
AM-101 is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompatible
gel for intratympanic injection. Emerging evidence suggests that NMDA receptors in the cochlea
play a major role in the occurrence of tinnitus following inner ear excitotoxicity, which is characterized by
excessive synaptic release of glutamate, the principal neurotransmitter in the auditory system. Cochlear
excitotoxicity may be triggered by, for example, trauma (e.g. exposure to excessive noise), neuroinflammation,
disturbances in inner ear blood supply (anoxia/ischemia), or the administration of certain ototoxic
drugs. It has been proposed that the upregulation of NMDA receptors induced by cochlear excitotoxicity is
responsible for aberrant excitation of auditory nerve fibres, which is perceived as tinnitus.
The development of AM-101 is based on research conducted at the INSERM Institute for Neurosciences of
Montpellier, France. The clinical development of AM-101 was initiated by Auris Medical in 2007 and comprises
3 clinical trials to date. Patents have been granted in more than 30 countries worldwide so far.
About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address
important unmet medical needs in otolaryngology. The Company is currently focusing on the development
of treatments for acute peripheral tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way
of intratympanic injection with biocompatible gel formulations. In addition, Auris Medical is pursuing earlystage
research and development projects. The Company was founded in 2003 and is headquartered in Basel,
Dr. Thomas Meyer, Managing Director, telephone +41 61 201 13 50, firstname.lastname@example.org
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