Meniere’s Disease affects an estimated 615,000 people in the United States, about 0.2% of the total population, making it quite a rare disease. Unfortunately, though Meniere’s is rare, about 45,000 new cases are diagnosed every year, and the symptoms are very real to many who struggle with this illness. A loss of balance, fluctuating hearing loss, vertigo, and tinnitus are all symptoms of Meniere’s Disease, but a new drug may be able to provide relief for symptoms that were previously treated with disappointing efficiency. Drug SPI-1005 has shown positive results for treating sensorineural hearing loss and tinnitus in patients with Meniere’s Disease, meeting the FDA’s Fast Track Designation requirements and giving hope of relief to many who struggle with this disease.
Meniere’s Disease (MD) is a chronic disorder that affects the inner ear and usually only affects one ear. Due to the inner ear’s responsibility for hearing and balance, MD can affect one’s balance and hearing capabilities, leading to symptoms of aural fullness, vertigo, and loss of hearing, usually brought on during “episodes” of the illness. Symptoms such as these can have a severe negative impact on a patient’s quality of life and ability to go through daily routines as the episodes are generally unpredictable. The current cause of MD is unknown, becoming a point of debate and research for medical professionals with conclusions ranging from autoimmune diseases, genetics, or changes in fluid in the tubes of your inner ear.
Currently, there is no cure for Meniere’s Disease, but some treatments may help relieve the severity of symptoms. Smoking, high salt diets, and alcohol consumption are known to make MD symptoms worse due to their effect on inner ear fluid, therefore, many treatments include diet and lifestyle changes, oral or locally injected steroids, or medication for motion sickness that may help with nausea and the severity of vertigo.
Though there are ways to relieve vertigo and motion sickness caused by MD, there was no effective treatment for hearing loss or tinnitus caused by the disease. Fortunately, positive top-line results from two completed studies by Seattle-based Sound Pharmaceuticals have shown that oral delivery of their SPI-1005 drug for 21 or 28 days improved tinnitus and restored sensorineural hearing loss in patients affected by MD. Because SPI-1005 is a drug to treat “serious conditions where the potential to address unmet medical need has been demonstrated”, this has qualified it for Fast Track Designation by the FDA.
Until the drug gets final approval, there are still many steps to take until it is in the hands of patients, such as reviews and meetings with the FDA, But Dr. Jonathan Kil, Co-Founder and CEO of Sound Pharmaceuticals is hopeful. “This is a major regulatory milestone for our most advanced clinical program to date.”
Drugs such as SPI-1005 are providing a path forward in treating symptoms for a previously untreatable disease. If you are suffering from symptoms of Meniere’s Disease, seek out the medical advice from a hearing health professional and don’t lose hope. As the science and healthcare industry make monumental advancements every year, efficient treatments like SPI-1005 may become more common as we treat new diseases and symptoms.