Ingelheim/Germany 22 June 2005 Boehringer Ingelheim today announced the launch of a new prolonged release tablet formulation of tamsulosin, its well established treatment for Lower Urinary Tract Symptoms (LUTS) due to benign prostatic hyperplasia (BPH). The new tablet formulation is based on an Oral Control Absorption System (OCAS®)* technology which provides for more consistent 24-hour drug release with reduced peak plasma concentration of tamsulosin.
As of April 15th,2005, this new small film-coated tablet will be marketed as Alna®OCAS® 0.4 mg in Germany. Other European Countries will follow in the market in the next months under the trademarks of Pradif® T (Greece, Italy, Portugal, Switzerland) and Urolosin® OCAS® (Spain). Launches in additional countries are anticipated in the future.
In placebo-controlled randomized pivotal trials Alna®OCAS® 0.4 mg tablet once daily has shown the well established efficacy of the current tamsulosin capsule while demonstrating placebo-like tolerability1,2.
One of the most bothersome symptoms in BPH patients which severely impacts the patients sleep and overall quality of life is frequent night-time urination (nocturia) 3. A recent placebo controlled study in BPH patients suffering from nocturia confirmed that the consistent 24-hour plasma concentration of Alna®OCAS® 0.4 mg tablet was associated with significant daytime and night-time symptom relief and significant improvement in quality of life4.
Unlike the tamsulosin capsule which must be taken after meals5, the new Alna®OCAS® tablet can be dosed independent of food intake. This advantage was confirmed in a study in the elderly comparing tamsulosin capsule and the new tablet under fasting conditions, where the use of the tablet was associated with smoother plasma concentrations and a lower incidence of blood pressure changes (orthostatic hypotension)6.
Tamsulosin is one of the best tolerated alpha-blockers currently available for the treatment of BPH. The new Alna®OCAS® tablet, with its improved pharmacokinetic profile, represents a further treatment advancement in terms of patient convenience and for some patients offers the potential for even better tolerability stated Prof. Martin Michel, leading expert in clinical pharmacology, Head of the Department of Pharmacology and Pharmacotherapy, University of Amsterdam, Netherlands.
Boehringer Ingelheim will continue to market Tamsulosin 0,4 mg capsules under the well-known tradenames FLOMAX®, ALNA®, JOSIR®, PRADIF®, SECOTEX® and UROLOSIN®.
Tamsulosin is a highly uroselective α1A/D alpha-blocker specifically developed for Benign Prostate Hyperplasia, a very common disease in elderly men.
Tamsulosin is the most frequently prescribed therapy in BPH primary care practice worldwide7 and is considered as the Gold Standard in the treatment of LUTS due to BPH.
Tamsulosin 0.4 mg once-daily without titration is effective in reducing either the voiding or storage symptoms, provides fast onset of action, established long term efficacy and safety and improving also Quality of Life8,9.
Tamsolusin OCAS is licensed from Yamanouchi Pharmaceutical Co., Ltd., Japan (now Astellas Pharma Inc.)
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the worlds 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 45 countries and nearly 36,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2004, Boehringer Ingelheim posted net sales of 8.2 billion euro while spending nearly one fifth of net sales in its largest business segment Prescription Medicines on research and development.
* OCAS®is a registered trademark of Yamanouchi (now Astellas Pharma Inc.)
Boehringer Ingelheim GmbH
55216 Ingelheim am Rhein
Phone: +49/6132/77 82 71
Fax: +49/6132/77 66 01
1 Chapple CR, Lorenz J, Mortensen R, Pauthner H, Reis MO, Schulman CC, Putten-Slob I van der: Tamsulosin oral controlled absorption system (OCAS) in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH): efficacy and tolerability in a phase 2b dose-response study. Eur Urol 4 (Suppl), 25-32 (2005)
2 Chapple CR, Al-Shukri SH, Gattegno B, Holmes S, Martinez-Sagarra JM, Scarpa RM, Vierssen Trip OB van, Vik V, Putten-Slob I van der: Tamsulosin oral controlled absorption system (OCAS) in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH): efficacy and tolerability in a placebo and active comparator controlled phase 3a study. Eur Urol 4 (Suppl), 33-44 (2005)
3 Asplund R, Aberg H Health of the elderly with regard to sleep and nocturnal micturition. Scand J Prim Health Care 10: 98-104 (1992)
4 Djavan B, Milani S, Davies J, Bolodeoku J: The impact of tamsulosin oral controlled absorption system (OCAS) on nocturia and the quality of sleep: preliminary results of a pilot study. Eur Urol 4 (Suppl), 61-68 (2005)
5 Michel MC, Korstanje C, Krauwinkel W: Cardiovascular safety of tamsulosin modified release in the fasted and fed state in elderly healthy subjects. Eur Urol 4 (Suppl), 9-14 (2005)
6 Michel MC, Korstanje C, Krauwinkel W, Shear M, Davies J, Quartel A: Cardiovascular safety of the oral controlled absorption system (OCAS) formulation of tamsulosin compared to the modified release (MR) formulation. Eur Urol 4 (Suppl), 53-60 (2005)
7 IMS data, 2004
8 Lepor H Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Urology 51 (6) , 892-900 (1998)
9 Narayan P, Evans CP, Moon T Long-term safety and efficacy of tamsulosin for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia. J Urol (Baltimore) 170 (2, Part 1) , 498-502 (2003)