Inura’s intraurethral ovulum is a first-of-a-kind solution that utilizes a novel route of drug administration to treat diseases of the bladder and lower urinary tract. The Pharma startup is now getting ready for their clinical trial phase to study various aspects of this novel drug delivery platform in women.
Overactive bladder (OAB) is a disabling chronic condition affecting around 15-20% of women over the age of 40 years. Characterized by urgency, frequency, nocturia (uncontrollable night-time voiding), and incontinence, it can cause fatigue, memory deficits, depression, embarrassment, increased risks of illnesses, and accidents. Existing medications have drastic side effects, causing 70-90% of the patients to discontinue treatments. Addressing this unmet disease and improving women’s lives, Inura Medical introduced the first-of-a-kind, patented female urethral ovulum.
The proprietary preparation allows for distributing an active pharmaceutical ingredient (API) directly to the surrounding tissues for rapid action. The first product contains Oxybutynin, which has been used for decades either as oral or transdermal therapy. The new treatment developed by Inura is expected to provide quick relief of symptoms with minimal side effects, solving the biggest problem for the patient.
Following successful preclinical studies, Inura is stepping up the ladder to clinical trials to study several aspects of Oxybutynin when administered through the urethral route. The clinical phase I study, conducted in healthy volunteers, will also determine how well women can tolerate administration through this approach.
Subsequently, the startup plans to perform the clinical phase II study to compare the urethral ovulum to the standard of treatment for OAB, to study the effectiveness and safety. “This proof-of-concept study will conclusively decide the clinical development path ahead,” states the startup.
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