Almirall presents to register the linaclotida in Europe for the treatment of syndrome of irritable bowel with constipation (IBS E).
Almirall presents to register the linaclotida in Europe for the treatment of syndrome of irritable bowel with constipation (IBS-E).
-the linaclotida has shown a statistically significant improvement in pain or abdominal discomfort both global relief of the symptoms of IBS – and (1,2)
-the SII-E is a gastrointestinal disorder that can negatively affect the quality of life and entailed considerable socio-economic consequences and psychological (3,4)
Barcelona, 2011-October Almirall, S.A. (ALM)(MC) announced on Thursday the filing of the application for authorisation for the marketing of the linaclotida (MAA in its acronym in English) to the European Medicines Agency (EMA). The linaclotida is an agonist of the recipient of the guanylate Cyclase (GC-C), indicated for the treatment of IBS-E. After its adoption, the linaclotida will be available in Europe under the brand name Constella ®.
“ The SII is associated to a significant reduction in the quality of life and the considerable consumption of health resources. In particular, persons suffering from IBS-E currently have few treatment options available. Patients and doctors are frustrated because of this lack of specific therapies for IBS-E ”, said Bertil Lindmark, CEO of r & d of Almirall. “ The results of clinical trials with linaclotida in SII-E have been extremely encouraging, and with this application we hope to soon offer patients in Europe this novel medicine, first in his class ”.
The MAA includes data from efficacy and safety of the programme of phase III, which includes two clinical trials to double-blind and controlled with placebo (1,2) and two open studies of long-term security. In total, more than 1,600 patients have received one dose of linaclotida or placebo once a day in the two controlled studies with placebo in people with IBS-E. Detailed results of these two studies will be presented at the Congress of the European Gastroenterology week (UEGW), to be held in Stockholm from 23 to 26 October 2011.
This request occurs after the submission of the registration to the Food and Drug Administration (FDA) last August, Ironwood Pharmaceuticals Inc. and its partner in the United States.UU. Forest Laboratories Inc.
Almirall obtained the license from Ironwood to develop and market the linaclotida in Europe.
Phase III studies
The efficacy and safety of linaclotida in the SII-E have been evaluated in two large studies of phase III, double-blind and controlled with placebo.(1,2) In both trials, the linaclotida proved to be significantly superior to placebo in improving pain or abdominal discomfort as the degree of symptom relief, and in the improvement of the frequency of deposicional habit, the consistency of the stool, the defecatorio effort and abdominal distention. This improvement was maintained throughout the period of treatment (12 and 26 weeks). Diarrhea was the adverse event most prevalent (linaclotida 20%, 3% placebo), generally mild to moderate intensity, and resulted in treatment discontinuation in only 5% of patients treated with linaclotida.
The linaclotida
The linaclotida, a first research medication in its class, is an agonist for receptor guanylate Cyclase type C (GC-C) that is located on the intestinal luminal surface. In preclinical models, the linaclotida reduced the visceral hypersensitivity, increased secretion of fluid and accelerated intestinal transit. Effects on intestinal transit and secretion – mediated by (cGMP) cyclic Guanosine monophosphate – it is believed that they also modulate the activity of local nerves to reduce pain. The linaclotida is a peptide which is administered by mouth, that acts locally in the intestine, without significant systemic exposure to therapeutic doses and administered once a day.
Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. are developing it, and after the adoption, will jointly promote the linaclotida in United States. Ironwood has granted the license of this product to Almirall to its development and marketing in Europe and Astellas Pharma Inc. to its development and marketing at Japan, Indonesia, Korea, Philippines, Taiwan and Thailand.
With constipation (IBS-E) irritable bowel syndrome
The SII is defined as a functional disorder of the bowel in which abdominal discomfort or pain are associated with defecation or a change in bowel habits, or well characteristics of defecation (5)
Rome III diagnostic criteria for gastrointestinal functional disorders include diagnosis of the SII6 criterion as:
pain or recurrent abdominal pain at least three days a month, in the past three months, associated with two or more of the following:
– improvement with defecation
-onset associated with a change in frequency of bowel movements
-onset associated with a change in the way (or appearance) depositions
the prevalence of IBS estimated at 10-15% of the populationEuropean n, puts this pathology at the level of other profile high as migraine (12%) and asthma (11%).)(7) It produces a substantial reduction in the quality of life, which is accompanied by socio-economic and psychological consequences considerable (3,4) and represents a significant proportion of gastrointestinal care, both in primary care and specialty care.
Due to the complex and diverse nature of this disease, there is no cure for IBS, and nor is there a treatment “ reference ”.(8) The SII-E is one of the four subtypes of clinically distinct from IBS. It is estimated that one-third of patients with IBS have SII-E (4,5,9) and therefore live with constipation and abdominal pain.
Almirall
Almirall is an international pharmaceutical company based on innovation and committed to health. With headquarters in Barcelona (Spain), Almirall researches, develops, produces and sells drugs own r & d and licensing with the aim of improving the health and well-being of the people.
the therapeutic areas in which concentrates its resources in research are related to the treatment of asthma, COPD (chronic obstructive pulmonary disease), gastrointestinal disorders, psoriasis and other sintomatologÃas dermatological.
Almirall drugs are currently present in over 70 countries. It has direct presence in Europe and Latin America through 12 subsidiaries.
Constella ® is a brand registered property of Ironwood Pharmaceuticals, Inc. and its use in Europe is pending approval by the regulatory authorities corresponding .
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references
(1) Rao S. et al. – Efficacy and Safety of Once Daily Linaclotide in Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial Followed by a 4-Week Randomized Withdrawal Period. Digestive Disease Week, May 7-10 2001, Chicago Abstract #: 845.
(2) chey, w. et al. – Efficacy and Safety of Once-Daily Linaclotide Administered Orally for 26 Weeks in Patients With SCI-C: Results From a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial. Digestive Disease Week, May 7-10 2001, Chicago Abstract #: 837.
(3) S Maxion-Bergemann, Thielecke F, Abel (f), Bergemann r. – Costs of irritable bowel syndrome in the UK and US. Pharmacoeconomics 2006; 24: 21 – 37.
(4) Davis RH. – Overcoming barriers in irritable bowel syndrome with constipation (SCI-C). J FamPract 2009; 58:S3 – S7.
(5) LongstrethGF, Thompson WG, CheyWD et al. – Functional Bowel Disorders. Gastroenterology 2006; 130: 1480-1491
(6) Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders.
(7) p. S. Hungin et al — The prevalence, patterns and impact of irritable bowel syndrome: an international survey of 40,000 subjects – Aliment PharmacolTher 2003; 17: 643 – 650.
(8) Camilleri M, Chang l. – Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory sweeper. Gastroenterology 2008; 135: 1877 – 1891.
(9) American College of Gastroenterology Task Force on Irritable Bowel Syndrome.An evidence-based position statement on the management of irritable bowel syndrome.Am J Gastroenterol 2009; 104 Suppl. 1:S1 – 35.
