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Oxybutynin or Oxytrol is an antispasmodic and anticholinergic drug
used in the treatment of overactive bladder. It was in March 2003
FDA ( US, Food and drug administration approved Oxytrol a
transdermal patch that has been designed so as to deliver Oxybutynin
continuously and consistently over three to four day interval after
application to intact skin. FDA approval was based on the clinical
trials conducted on the patients at two levels, controlled studies
and one open label extension study.
A study was conducted on around 520 cases and placebo. A dosage
levels of 1.3, 2.6, 3.9 Oxytrol was administered and the results
indicated the improvement shown in the 520 subjects as against in
placebo. The results indicated a reduction in the urine frequency
and urinary void volume. The open label treatment continued for a
period of 30 to 40 weeks and the subjects had the urge or mixed
incontinence with these episodes of incontinence at least 10 per
week.
In 2006 Mylan Laboratories Inc declared that it has received the FDA
approval for its pill Oxybutynin Chloride extended release tablets
5mg and 10 mg. These pills are the generic version of Alza’s
Corporation’s Ditropan XL ® ER tablets. Mylan Laboratories Inc is a
leading pharmaceutical company with three principal subsidiaries,
Mylan Pharmaceuticals Inc, Mylan Technologies Inc and UDL
Laboratories Inc. Mylan is one of the leading manufacturer and
marketer of various generic products.
Alza Corporation Ditropan XL had a US sale of around $ 380million
during the year 2006. All this indicates that the treatment with
Oxybutynin is considered to be the most best and effective in the
near future.
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