Healthcare Industry News:  methylnaltrexone 

Biopharmaceuticals Regulatory

 News Release - July 7, 2008

European Medicines Agency (EMEA) Approves Relistor(TM) The First-in-Class Treatment of Opioid-Induced Constipation (OIC) in Advanced-Illness Patients

First-in-Class Treatment set to Provide a New and Important Targeted
Treatment for Distressing and near Universal Side Effect in Patients
Receiving Opioids for Pain Relief as Part of Palliative Care

MAIDENHEAD, England, July 7 (HSMN NewsFeed) -- Wyeth Pharmaceuticals, today 3rd July, announced that it has received EMEA marketing approval for Relistor(TM) (methylnaltrexone bromide) subcutaneous injection. This first-in-class treatment is indicated for opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to the usual laxative therapy has not been sufficient.

Relistor is now approved for use across all 27 EU member states as well as Iceland, Norway, and Liechtenstein. Currently, Relistor is already approved for use in OIC in the US and Canada, and undergoing regulatory review in Australia. Commercial launch of Relistor in Europe will be rolled out on a country-by-country basis, with the first launch anticipated to occur later this month.

Stevo Knezevic, Chief Medical Officer EMEA for Wyeth Europa said: "We are delighted with the EMEA's approval of Relistor. Both patients with advanced illness and their physicians will have the option of an innovative first-in-class treatment which finally targets the underlying cause of opioid-induced constipation. We look forward to launching Relistor throughout Europe."

As Europe's population ages, so the number of patients living with advanced illness is likely to increase.(1) Pain relief is often a key part of palliative care and opioids are routinely used.(2) However, the effective pain relief provided by opioids is often accompanied with a less welcome side effect of opioid-induced constipation (OIC). OIC is a near universal occurrence in patients receiving opioid analgesics as part of palliative care (3,4) and can be so severe, that it may result in patients choosing to sacrifice their pain medication to mitigate the problem.

Commenting on the approval for Relistor, Professor Lukas Radbruch, head of the Department for Palliative Care, University Hospital Aachen, Germany, and President of the European Association of Palliative Care, explains the challenges facing physicians in managing advanced-illness patients with OIC, an often overlooked and under-diagnosed side effect of pain management: "For the large number of patients receiving palliative care, opioids provide effective pain relief and are the routine analgesic treatment for patients with advanced illness. However, they often cause the unwelcome and distressing side effect of constipation, so severe that patients can prefer to reduce their opioid pain medication to minimise their discomfort. That is why it is so important that there are treatments available that target the underlying mechanisms of OIC, allowing pain to be managed while preserving quality of life in these patients"

Relistor (methylnaltrexone bromide) is the first in a new class of peripherally acting mu-opioid receptor antagonists that reverse the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. It is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care when response to usual laxative therapy has not been sufficient. It is administered via subcutaneous injection.

Relistor has a novel mechanism of action which has been clinically shown to directly target the underlying cause of OIC: it blocks the binding of the opioids to peripheral mu-opioid receptors within the gastrointestinal tract (GI), thus reversing the slowing effects of opioids on the GI tract and bowel without reducing their pain-relieving effect. Traditional options with which to manage OIC include laxatives and stool softeners given as soon as opioids are started. In spite of aggressive use of these agents, symptoms often continue and their clinical efficacy is unpredictable.

We estimate that each year, more than 1.5 million Americans receive palliative care due to an advanced illness, and other end-stage diseases such as incurable cancer.(5,6) Similar figures are not available for Europe as a whole, which may be considered indicative of the fact that this is an overlooked condition and an area of unmet medical need.

About Relistor

Relistor is the first in a new class of peripherally acting mu-opioid receptor antagonist. Relistor targets the underlying cause of OIC. It blocks the binding of opioids to peripheral mu-opioid receptors, in the gastrointestinal (GI) tract, reversing the slowing effects of opioids on the GI tract without diminishing their analgesic effect via the central nervous system receptors.(7)

In April 2008 the FDA approved Relistor subcutaneous injection for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient in the USA. In March, 2008, Relistor received approval in Canada for the treatment of OIC in patients with advanced illness receiving palliative care. In August 2007, Wyeth submitted a marketing application to the Australian Therapeutic Goods Administration, and a decision is expected around Q3 2008.

About Wyeth

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

Editor's Notes:

Additional information on Wyeth is available at


1. Davies E, Higginson I. Better Palliative Care for Older People. WHO, 2004. df

2. Gutstein HB, Akil H. Opioid Analgesics. In: Brunton LL, Lazo JS, Parker KL, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 11th Ed. New York, NY: McGraw-Hill; 2006: 547-590

3. Fallon MT. Constipation in cancer patients: prevalence, pathogenesis, and cost-related issues. Eur J Pain. 1999;3(suppl A):3-7

4. Emanuel EJ, Emanuel LL. Palliative and end-of-life care. In: Kasper DL, Braunwald E, Fauci AS, et al, eds. Harrison's Principles of Internal Medicine. 16th ed. New York, NY: McGraw-Hill; 2005:53-66

5. MiniƱo AM, Heron M, Murphy SL, et al. Deaths: final data for 2004. Health E-Stats. Released November 24, 2006. Available at: 4.htm. Accessed March 9, 2007

6. National Hospice and Palliative Care Organization. NHPCO's Facts and Figures -

2005 Findings. Available at: Accessed May 30, 2007

7. Thomas J., Karver, S, Cooney GA: methylnaltrexone for Opioid Induced Constipation in Advanced Illness. New England Journal of Medicine, May 29, 2008:22, vol. 358: 2332-2343.

Source: Wyeth

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