The Phase 2 program for ADL5945 includes two trials, one testing once-daily dosing and the other testing twice-daily dosing. The primary outcome for the trials is change from baseline in the weekly average number of SBMs during the four-week treatment period. A two-week screening period precedes the four weeks of treatment. The Phase 2 trials will enroll over 200 total adult patients with non-cancer related chronic pain who are taking opioids for pain management. Adolor also is using the Phase 2 trials to validate a patient reported outcomes (PRO) measurement instrument designed to evaluate symptoms beyond constipation that could eventually be used to broaden the indication and/or support claims in the product label.In addition to developing ADL5945 for opioid induced constipation and associated symptoms, Adolor markets ENTEREG, which is indicated to accelerate the time to upper and lower GI recovery following partial large or small bowel resection surgery with primary anastomosis. Adolor recently announced an agreement to acquire full ownership of ENTEREG from GlaxoSmithKline. Adolor also has a strong pipeline of therapies targeting unmet medical needs in the area of pain management. The Company has completed Phase 1 studies of ADL6906 (beloxepin), a dual norepinephrine reuptake inhibitor and 5-HT 2 (serotonin) receptor antagonist for the treatment of pain. Additional pipeline candidates include the backup development candidate for ADL5945, ADL7445, and a group of centrally-acting mu opioid receptor (CAMOR) antagonists with potential applications as an adjuvant to l-DOPA therapy for Parkinson’s disease. Dr. McDonald’s full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors also will provide ongoing coverage and event-based research updates on the Company as developments occur. Important Disclosures : The research report described in this press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell securities. The securities discussed in LSA research reports may be unsuitable for some investors depending on their specific investment objectives, financial status, risk profile, or particular needs. Investors should consider LSA reports as only a single factor in making their investment decisions and should not rely solely on these reports in evaluating whether or not to buy or sell the securities of the subject company.
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