Regurin XL capsule for the treatment of OAB launched in UK

Sep 7 2009

Regurin(R) XL (trospium chloride), a once-daily, prolonged-release capsule to treat patients with overactive bladder (OAB) has been launched in the UK. Regurin(R) XL provides rapid, significant and consistent improvements in the symptoms of OAB1 and has a reduced potential for central nervous system (CNS) side effects.

OAB, also known as irritable bladder, is a condition that results from sudden, involuntary contraction of the muscle in the wall of the urinary bladder. Key symptoms of OAB include frequent urination, urgency of urination, and urge incontinence. Urinary incontinence is a distressing and often embarrassing problem estimated to affect over a third of women in the UK over 40(8).

By rapidly, significantly and consistently improving the symptoms of OAB as early as day 5 of treatment., a statistically significantly higher number of patients in placebo controlled clinical trials achieved a reduction in urgency and wet days by week 12 with Regurin(R) XL. Furthermore, Regurin(R) XL has the benefit of not crossing the blood- brain barrier, or the blood eye barrier reducing the CNS side effects sometimes associated with OAB treatments.

"Overactive bladder has a significant, and often underestimated, impact on the quality of life of all patients. In elderly dependent patients OAB can cause breakdown in care-giving relationships and even increase the likelihood of patients being admitted to a nursing home , said Professor Linda Cardozo, Kings College Hospital, London. "It is important to effectively treat OAB, to maintain confidence and independence in all patients. Ensuring patient compliance is an important consideration in treating patients with OAB. Therefore, the availability of cost effective, tried and tested treatment, with the convenience of once-daily dosing, and minimal side effects is welcome news for physicians and their patients".

Clinical trials showed the incidence of dry mouth, and constipation also occurs less frequently in patients on Regurin(R) XL compared to all other antimuscarinic agents, and approximately 50% less than Regurin(R) 20mg twice daily. In addition, Regurin(R) XL has a low potential for interaction with concomitantly administered medications.

Geoff McMillan, Chief Executive Officer of SEP, said: "As a young Company with a focus on Urology, the launch of Regurin XL is very exciting. Urinary incontinence is a very common and embarrassing problem and we believe that Regurin XL offers significant benefits for patients, their physicians and the health service as a whole."

Regurin(R) XL is licensed for use in men and women to treat the symptoms of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with OAB.

Exclusive distribution rights in the UK for Regurin(R) XL (trospium chloride), have been granted to Specialty European Pharma Ltd (SEP), a UK based, urology focused, specialty pharmaceutical company by Rottapharm|Madaus.