A New Nasal Spray To Treat Tinnitus: Does GW-TT2 Work?

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Now that the ringing or buzzing in your ear has a name—tinnitus—it’s time to explore the next steps in overcoming these phantom sounds. Tinnitus, when left untreated, can be a nuisance, and interfere with normal enjoyment of life. There’s no cure for tinnitus yet, but there are management techniques and treatments that have proven helpful for some patients. 

Many patients are still hoping for some type of drug solution as a cure. The latest update from Gateway Biotechnology on their promising tinnitus drug candidate GW-TT2 offers a possible candidate for treatment. Although not a cure, Ccould this nasal spray be the next step in tinnitus treatment? Like always, the experts at Treble Health took a closer look at the science to see if there’s more to it, or if this is another treatment meant to rile up the growing tinnitus community. Here’s what we found:

What is GW-TT2? 

GW-TT2 from Gateway Biotechnology is a repurposed drug originally known as Nimodipine, which is currently being developed as a nasal spray specifically for the treatment of noise-induced tinnitus. Early studies using animal models have demonstrated some effectiveness (of Nimodipine). Unlike the oxytocin nasal spray we discussed in another Sound Science video, the Nimodipine sets itself apart by targeting the abnormal neural hyperactivity in the central auditory nervous system, which experts believe is the key factor in noise-induced tinnitus. 

"As a recent graduate who’s achieved stage four habituation, I cannot thank Treble Health enough for getting me to the finish line."
"As a recent graduate who’s achieved stage four habituation, I cannot thank Treble Health enough for getting me to the finish line."
– Louis
Book a free consultation to learn which Treble Health solution is right for you. Join Louis and thousands more who have found lasting tinnitus relief.

Nimodipine also sets itself apart as one of the few drugs marketed to tinnitus patients that have the potential for FDA approval. Recent developments have shown significant progress, as the FDA has provided positive feedback on the pre-investigation new drug application. The next step are clinical trials, and researchers hope this can become a more accessible and successful tinnitus treatment. This could be great for members of the tinnitus community, from patients to healthcare providers, as tinnitus has long lacked FDA-approved drug options. 

This treatment was developed as a nasal spray to improve the delivery of the drug to the brain and reduce the sometimes bothersome side effects of oral and IV delivery. The researchers believe that Nimodipine is able to bypass one of the suspected mechanisms of tinnitus: an overabundance of calcium in the hair cells of the ear which sends abnormal signals to the brain. They believe the nasal spray may help control the flow of calcium by blocking these channels, thus reducing the abnormal signals and therefore lessening the symptoms of tinnitus. 

Can GW-TT2 cure tinnitus? 

Before Nimodipine was even considered for tinnitus, it was already an FDA-approved drug for treating brain damage after a specific type of stroke. This medication is generally taken as a pill or tablet, but is sometimes available as an injection, generally in Europe. Nimodipine has also been used off-label to treat other conditions such as vertigo, migraines, and Meniere’s disease, which are commonly are associated with tinnitus.

As for being an effective treatment for tinnitus, there’s still a lot we just don’t know. Nimodipine for tinnitus is still in the developmental stages, and while there’s positive feedback coming from the FDA, we still have quite a ways to go.

Gateway Biotechnology began manufacturing GW-TT2 for clinical trials, toxicity testing on animals, and stability testing under good manufacturing practices. Preclinical studies using an established animal model for noise-induced tinnitus have shown some promise. The goals of the clinical trial are to produce the first-ever FDA-approved drug for people with noise-induced tinnitus, with a special emphasis on military personnel.

In a 2021 study in Korea of about 60 patients, over 65% saw an improvement in their tinnitus. However, this is a small study with a limited sample size, and seasoned researchers will tell you that clinical studies like these sometimes don’t pan out, despite millions of dollars of funding and numerous trials. This treatment has to prove better than the placebo in human trials, which is historically hard for tinnitus cases. But, this is how we’ll know whether it works or not.

GW-TT2 joins a list of potential hopefuls for tinnitus treatment, however, it is one of the most advanced drug candidates currently in development for tinnitus treatment. New research and initiatives for tinnitus treatment are always exciting, and patients and professionals alike are encouraged to stay open to emerging treatments and complementary approaches. 

What Actually Works (So Far)

Experts are hopeful, but there’s still no cure for tinnitus just yet. In some instances, tinnitus can just disappear on its own, even without targeted treatments for the phantom sounds. The best approach to tinnitus is always identifying the root cause of the tinnitus. This isn’t so straightforward, and in most cases, the cause of the tinnitus is not always clear. 

Tinnitus is very complex. It can be caused by something with a simple fix, like removing an overabundance of wax in the ear canal, or something as complex as an acoustic neuroma that may require surgical removal. Other conditions such as atherosclerosis, lupus, and high blood pressure can cause tinnitus, and oftentimes, the medications used to treat these conditions end up indirectly addressing the tinnitus symptoms as it alleviates the symptoms of the medical condition. 

Other evidence-based treatments for tinnitus include:

  • Tinnitus Retraining Therapy (TRT)– TRT is considered the gold-standard treatment for tinnitus. This revolutionary approach combines Cognitive Behavioral Therapy (CBT) with sound therapy to address the psychological symptoms of tinnitus while masking the phantom sounds. The goal of Tinnitus Retraining Therapy (TRT) is promoting habituation, or teaching the brain to ignore the tinnitus.
  • Behavioral therapy– Since tinnitus can evoke strong emotional responses, experts recommend behavioral therapy to manage the psychological symptoms to complement other approaches for the best outcome for patients. Cognitive Behavioral Therapy (CBT) or talk therapy is one of the most commonly used behavioral therapies for tinnitus, as well as Mindfulness-Based Stress Reduction (MSBR) and Acceptance and Commitment Therapy (ACT). Progressive Tinnitus Management (PTM) and Tinnitus Activities Treatment (TAT) are behavioral approaches developed specifically for tinnitus and its often unique and complex set of symptoms.  
  • Relaxation techniques– Physical and emotional stress and tension have been known to trigger or worsen tinnitus. People with tinnitus are encouraged to relax both the mind and body to reduce tinnitus symptoms, and improve overall mental health and well-being. Tinnitus patients can benefit from relaxation techniques such as massages, yoga, and other forms of exercise, or socializing with friends and family! These simple activities can make a real difference for people who suffer from chronic tinnitus.
  • Hearing technology- While tinnitus was formerly thought to indicate an issue with hearing or the ear, in many instances, this is usually the case. Over 60% of tinnitus patients with tinnitus also have some degree of hearing loss. This figure has the potential to increase as the standard hearing test conducted in a physician’s office is not sensitive enough to detect all types of hearing loss. (maybe link to our blog about hidden hearing loss here?) Usually, treating any hearing loss treats tinnitus symptoms, whether that’s with hearing aids, or cochlear implants. Hearing aids can also address the hearing loss and tinnitus at the same time. People with tinnitus are also encouraged to use hearing protection such as ear muffs and plugs to reduce exposure to loud noises which can trigger tinnitus. 
  • Sound therapy– Masking tinnitus sounds can help the brain ignore the tinnitus sound and focus on something else. Sound therapy is also useful as sound enrichment, as, contrary to popular belief, a soundless environment increases the perception of tinnitus, just like being exposed to excessive or loud noise. 
  • TMJ Treatment– Tinnitus that has been linked to movement or pressure in the physical condition (of the body) such as head and neck trauma, jaw abnormalities, and even injections can be treated with TMJ treatment such as botox, orthodontic work, and certain surgeries. 

Experimental Therapies

With the number of tinnitus cases increasing every year, finding a cure, or at least an effective or accessible treatment is all the more important. As more research is announced and released to the public, people with tinnitus can begin to feel more hopeful about the ringing or buzzing sounds in one or both of their ears. 

Here are some of the experimental therapies the American Tinnitus Association believes show some promise:

  • Non-invasive electrical stimulation– Repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Direct Current Stimulation (tDCS) are both non-invasive methods of delivering electrical stimulation to reduce abnormal neural activity. These treatments are still in the experimental stage, and it will be quite some time before these become viable options for the everyday tinnitus patient.
  • Vagus nerve stimulation (VNS)– The vagus nerve regulates the parasympathetic nervous system which affects aspects such as mood, digestion, heart rate, and immunity. The connection to tinnitus is not yet clear, however, VNS has shown effectiveness in treating epilepsy and depression. Some believe the same may be true for tinnitus, but more research is needed before this becomes available for patients outside of a research setting.
  • Deep brain stimulation (DBS)– Already in use for patients with Parkinson’s disease, tremors, tourettes, and Obsessive-Compulsive Disorder(OCD), Deep Brain Stimulation (DBS) has demonstrated its effectiveness at targeting abnormal neural activity. Researchers hope that once able to pinpoint the specific area of the brain affected by the neural activity, they can make headway with DBS for tinnitus. Unlike rTMS and tDCS, DBS is more invasive and includes surgical implantation of electrodes into the brain. 

Tackling Tinnitus With the Treble Health Team

We’re still a long way from a nasal spray that can truly stop or cure tinnitus symptoms. But, the experts at Treble Health have already identified several techniques and therapies that have transformed the lives of thousands of tinnitus patients. We understand how tinnitus symptoms can hamper daily life and are dedicated to helping people with tinnitus find actionable solutions. 

Join the growing tinnitus community, and get a comprehensive evaluation of your tinnitus symptoms with leading tinnitus experts from Treble Health. Schedule a 20-minute telehealth session with the audiology team to get started today. This complimentary consultation will dig deeper into the root cause and effects of your tinnitus to customize a treatment plan just for you. A quieter, more peaceful life awaits!

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