Detrusor

Detrol is a drug that is FDA-approved for treatment of overactive bladder (we docs like to call it detrusor instability). ❋ Aka TBTAM (2008)

For, in fact, neither the bladder nor rectum ever acts voluntarily per se any more than the stomach does, and therefore the name "detrusor" urinae, as applied to the muscular coat investing the bladder, is as much a misnomer (if it be meant that the act of voiding the organ at will be dependent upon it) as would be the name "detrusor" applied to the muscular coat of the stomach, under the meaning that this were the agent in the spasmodic effort of vomiting. ❋ Joseph Maclise (N/A)

Austin JC, Chacko SK, DiSanto M, Canning DA, Zderic SA: A male murine model of partial bladder outlet obstruction reveals changes in detrusor morphology, contractility and myosin isoform expression. ❋ Unknown (2010)

Other health implications of urinary incontinence in people living with MS or spinal cord injury include skin irritation and ulcers, kidney failure 4,11 and recurrent urinary tract infections, which may lead to serious health consequences, if the overactivity of the detrusor muscle is not treated.

InvestiGation of purified Neurotoxin complex In neurogenic deTrusor overactivitY was Allergan's phase III clinical programme evaluating the safety and efficacy of BOTOX® as a treatment in patients suffering from urinary incontinence due to neurogenic detrusor overactivity.

So I think whether we have the idiopathic trial going or not, will not change what the FDA does for neurogenic detrusor overactivity license.

The French Regulatory Agency, AFSSAPS, made France the first country to -- European country to issue a Positive Opinion for BOTOX for urinary incontinence associated with neurogenic detrusor overactivity with a license to be issued in due course.

Urinary incontinence in patients with MS or SCI is frequently caused by a condition called neurogenic detrusor overactivity NDO, which results in involuntary contractions of the bladder during the filling stage when the bladder should be relaxed.

DIGNITY: The largest clinical trial programme in neurogenic detrusor overactivity

We remain excited about the strength of our emerging urology pipeline, led by BOTOX for neurogenic detrusor overactivity, which was filed with the FDA, as well as EMEA and Health Canada in Q4.

Clearly, the next catalyst for this franchise is the anticipated FDA and the European approval to BOTOX for incontinence due to detrusor overactivity associated with the neurological condition.

Maybe one other comment, we were discussing regarding the question on neurogenic detrusor overactivity for BOTOX, in fact we have not received priority review.

On June 17, 2011, Allergan announced that the French license committee of the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) granted a Positive Opinion for BOTOX® (botulinum toxin type A) as a treatment for urinary incontinence associated with neurogenic detrusor overactivity, not controlled with an anticholinergic treatment, in people with spinal cord injury or multiple sclerosis who are willing and able to use a catheter to empty their bladder.

Patients were randomised to receive a physician-administered single treatment of placebo, 200 or 300 Units of BOTOX® injected as one procedure into the detrusor muscle using a rigid or flexible cystoscope.

Urodynamic testing shows that the most common abnormalities are detrusor overactivity, detrusor-sphincter dyssynergia, ❋ Game (2010)

The aim of the study presented in the Surgery in Motion section of European Urology was to propose and describe the steps of a new technique of surgical dissection that maximises the preservation of the periprostatic anatomy by keeping intact the pubovesical complex (PVC; i.e. detrusor apron with pubovesical ligaments). ❋ Unknown (2010)