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DelNova | Development Path for ReViVox™ for Overactive Bladder (OAB)
 

Therapeutics

Opportunity

Overactive Bladder (OAB) has an estimated of 16% is the U.S. (NOBLE Study). OAB can lead to sleep disturbance, depression, breakdown of skin due to leakage, fall-related injuries, admission to a medical facility, prolonged hospital stays, and lower quality of life (DataMonitor, 2018). OAB symptoms– including a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency)–may be treated with botulinum-Type A toxin injections such as BOTOX®.

While botulinum toxin administration for OAB has grown since the 2011 approval of Bladder BOTOX, adverse events are most commonly caused by injector inexperience. These temporary undesirable side effects can last from weeks to months. In the case of bladder dysfunction, the most common adverse effects include urinary infection and urinary retention. There is currently no remedy for urinary retention after botulinum-Type A toxin injections, other than waiting for the drug action to subside.

overactive-bladder

Depending on the severity of post-volume retention the patient may need to self-catheterize to avoid the onset of more serious conditions such as infection, and kidney stones.  Patients are not considered as candidates for botulinum therapy for OAB unless they are willing and capable of performing self-catheterization The incidence of urinary retention requiring self-catherization is more common in the elderly population.