Antares Pharma

Anturol® Gel

Pursuing a new option for patients

Anturol® is a novel treatment for the delivery of the anticholinergic drug, oxybutynin, approved Dec. 7, 2011 by the FDA for the management of overactive bladder.  Delivered using a metered dose pump, Anturol gel is an easy-to-use therapy which allows efficacious doses of drug to be systemically absorbed through the skin in a controlled manner.  Transdermal delivery of oxybutynin is a convenient and effective method of dosing and significantly reduces the anticholinergic side effects commonly associated with oral medications for overactive bladder, e.g., dry mouth.

Anturol® is licensed to Watson Pharmaceuticals in the U.S and Canada.  Antares is seeking qualified marketing partners for Anturol® in other major territories.

Overactive Bladder Syndrome

Several large population studies have reported that overactive bladder  (OAB) affects approximately 16% of adults and that the incidence increases with age. It is believed that around 100 million people worldwide experience symptoms of OAB, with women being affected more than men. Urinary incontinence in the elderly is a particular problem with up to 50% of the inhabitants in US nursing homes suffering from symptoms.
Pharmacotherapy relies on the use of anticholinergic drugs. The rationale for using anticholinergic drugs is to block the parasympathetic acetylcholine pathway and thus abolish or reduce the intensity of detrusor muscle contraction.

Rationale for Transdermal Oxybutynin 

Better efficacy and safety = better compliance 

Oxybutynin has antimuscarinic and antispasmodic effects on smooth muscle and is used to treat urgency and incontinence in neurogenic bladder disorders and idiopathic detrusor instability, and in nocturnal enuresis.   Oxybutynin first approved in 1975 and still accounts for about 35% of prescriptions written today to treat OAB.

The main active metabolite of oxybutynin is desethyloxybutynin (DEO), which has a similar anticholinergic effect to oxybutynin, but is primarily responsible for the anticholinergic side effects e.g., dry mouth, dry eyes, constipation or nausea.  Transdermal delivery of oxybutynin avoids first-pass metabolism in the liver, thereby reducing the formation of the DEO metabolite and associated side effects.  Clinical studies with a transdermal oxybutynin patch, in fact, reported anticholinergic side effect comparable to placebo.  However, skin irritations occurred in up to 17% of patients.

Therefore, an oxybutynin treatment combining the advantages of transdermal delivery without the adverse effects associated with oral medications and application site issues should improve the quality of life for the patient and offers a strong attractive commercial opportunity.