The most common treatment-emergent adverse events (>10%) while on ALO-02 were nausea, constipation, vomiting and headache. The most common serious adverse events were acute myocardial infarction, non-cardiac chest pain, pneumonia, convulsion, and kidney stones, each of which occurred in 2 patients. A total of 237 (60%) patients discontinued from the study over the one-year study period, with 19 percent of patients reporting adverse events as the primary reason for discontinuation. The adverse events that most commonly (>2%) lead to discontinuation were nausea and constipation. The discontinuation rate was within the expected range based on similar long-term safety studies with other extended-release opioid formulations.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of October 11, 2012. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.This release contains forward-looking information about a product candidate, ALO-02, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for ALO-02 as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K.
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