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Dr Reddy’s launches solifenacin (Bispec) for overactive bladder disease in India

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Thursday, June 25, 2009, 8:27 This news item was posted in health category and has 0 Comments so far.

Solifenacin has lesser side-effects than other leading drugs to treat inability to control urination.

India’s generic major Dr. Reddy’s Laboratories Ltd has launched Bispec (solifenacin succinate) used in the management of over-active bladder in India.

Overactive bladder syndrome is a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination.

Bispec (solifenacin succinate) is the best-in-class for over-active bladder diseases and it has lesser incidence of dry mouth and constipation. The most common side effects of solifenacin are dry mouth, blurred vision, and constipation.

People suffering from overactive bladder disease have a warning time of about 12 seconds. Solifenacin succinate helps increase the warning time to about 32 seconds. Warning time is the period between first sensation of urgency and urination in patients with over-active bladder syndrome.

Solifenacin belongs to a class of medications called anticholinergics. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. By preventing the binding of acetylcholine to these receptors, solifenacin reduces smooth muscle tone in the bladder, allowing the bladder to retain larger volumes of urine and reducing the number of micturition, urgency and incontinence episodes. Because of a long elimination half life, a once-a-day dose can offer 24 hour control of the urinary bladder smooth muscle tone.

Solifenacin succinate is marketed under the trade name Vesicare, is a urinary antispasmodic of the anticholinergic class. It is marketed and manufactured by Astellas and GlaxoSmithKline.

Bispec (solifencin succinate) is available in tablet form, and in dosages of 5 mg and 10 mg.

The market size for products used in the treatment of over-active bladder is about Rs 194 million growing at 7% ( source ORG MAT April 2009)

Other leading products for treatment of overactive bladder are tolterodine (Detrol) and oxybutynin (Oxytrol). These drugs often cause unpleasant side effects and many patients stop therapy for this reason. Trospium (Sanctura) is water-soluble and therefore less likely to cross from the blood into the central nervous system; this reduces some of the side effects compared to oxybutynin. Darifenacin (Enablex) is more selective for the bladder than older agents and may reduce side effects for this reason.

Solifenacin acts by competitively inhibiting acetyl choline from binding to cholinergic receptors present in bladder. This reduces bladder contractions and improves warning time in over active bladder patients.  Solifenacin succinate is highly receptor (M3) specific and has superior pharmacokinetic profile

TORQ is Dr Reddy’s another brand in this segment.

Established in 1984, Dr. Reddy’s Laboratories is an emerging global pharmaceutical company. Dr Reddy’s has three core businesses: Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products. Our products are marketed globally, with a focus on India, US, UK, Germany and Russia.

Dr Reddy’s Laboratories  posted a 3.76 per cent drop in net profit at Rs 156.1 crore for the fourth quarter ended March 31, 2009, as compared to Rs 162.2 crore in the corresponding period a year ago.Dr Reddy’s gross earnings rose by 12.36 per cent to Rs 1,166.5 crore for the quarter under review as against Rs 1,038.1 crore.

As per the audited consolidated results, the group has posted a net loss attributable to the shareholders of the parent of Rs 917.2 crore for the year ended March 31, 2009 as compared to a net profit of Rs 438.1 crore for the previous corresponding year.

Dr Reddy’s has written down $290 million against its German unit Betapharm resulting in a March quarter loss.

Dr Reddy’s Laboratories decided to wind up its proprietary products development to Aurigene -a wholly-owned arm, as part of a major restructuring operation to offset the fourth quarter losses incurred following the write-down of $290 million against the German unit Betapharm.

Dr Reddy’s also decided to close down research facility in Atlanta in the United States.

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