Adolor Corporation (NasdaqGM: ADLR) today announced that it has completed enrollment in its Phase 2 clinical evaluation of ADL5945 in chronic, non-cancer pain patients with opioid-induced constipation (OIC).

Adolor is conducting two Phase 2 studies of ADL5945 in OIC patients in parallel. The first study is evaluating two doses of ADL5945 – 0.10 mg and 0.25 mg – given twice daily versus placebo over a 4-week, double-blind treatment period. The second study, of similar design, is evaluating 0.25 mg of ADL5945 given once daily versus placebo. The trials have enrolled 40 or more patients in each arm, for a combined total of over 200 patients.

“Enrollment has progressed quite well in these studies,” said Michael R. Dougherty, President and Chief Executive Officer. “We look forward to reporting results in the third quarter of this year, and to advancing ADL5945 into pivotal testing in the first quarter of 2012. OIC is a frequent and serious consequence of long-term opioid-based pain management and an effective treatment for this condition remains an unmet medical need.”

About ADL5945

ADL5945 is a potent, peripherally-acting mu opioid receptor antagonist intended to block the adverse effects of opioid analgesics on the GI tract without compromising centrally-mediated analgesia. Peripheral mu opioid receptors in the GI tract regulate functions such as motility, secretion and absorption. Stimulation of these GI mu opioid receptors by morphine, or other opioid analgesics, disrupts normal gut motility. Ultimately, this results in constipation, as well as other associated burdensome GI symptoms.

During 2010, Adolor completed single dose and multiple-ascending dose studies of ADL5945 that enrolled both healthy volunteers and chronic non-cancer pain patients on long-term opioid therapy with OIC. At target therapeutic doses, ADL5945 was well tolerated and, in patients with OIC, produced greater increases (over baseline) in weekly average number of spontaneous bowel movements as compared with placebo.

About OIC

According to IMS Health, over 250 million opioid prescriptions are written annually in the United States. For those patients treated with prescription opioids for long term pain management, it is estimated that approximately 50 percent will develop constipation. Currently, there are no FDA-approved therapies to treat opioid induced constipation in patients with chronic non-cancer pain.

About Adolor

Adolor Corporation is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain and pain management products.

Adolor's first approved product in the United States is ENTEREG® (alvimopan), which is indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have registered in and met all of the requirements for the ENTEREG Access Support and Education (E.A.S.E.) program may use ENTEREG. For more information on ENTEREG, including its full prescribing information, the Boxed Warning regarding short-term hospital use and the E.A.S.E.® Program, visit www.ENTEREG.com. The Company co-promotes ENTEREG in collaboration with GSK.

The Company's research and development pipeline includes: ADL5945 and ADL7445, novel mu opioid receptor antagonists undergoing clinical development for chronic OIC; and several earlier-stage compounds under development for the management of pain and CNS disorders.

For more information, visit www.adolor.com.

Forward-Looking Statements

This press release, and oral statements made with respect to information contained in this release, may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide Adolor’s current expectations or forecasts of future events. These may include statements regarding market prospects for ENTEREG; the development of potential pharmaceutical products, including ADL5945; the timetables for the release of clinical results for the Phase 2 studies of ADL5945 and the initiation of pivotal testing; prospects for regulatory approvals; anticipated scientific progress on Adolor’s research programs; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning or that otherwise express contingencies, goals, targets or future development. These statements are based upon management’s current expectations and are subject to risks and uncertainties, known and unknown, that could cause actual results and developments to differ materially from those expressed or implied in such statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries, as well as more specific risks and uncertainties facing Adolor such as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Adolor urges you to carefully review and consider the disclosures found in its filings which are available at www.sec.gov and from Adolor at www.adolor.com. Given the uncertainties affecting pharmaceutical companies such as Adolor, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Adolor undertakes no obligation to publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise, except as may be required by law.

This press release is available on the website http://www.adolor.com.

Adolor Corp. (MM) (NASDAQ:ADLR)
Historical Stock Chart
From Jun 2024 to Jul 2024 Click Here for more Adolor Corp. (MM) Charts.
Adolor Corp. (MM) (NASDAQ:ADLR)
Historical Stock Chart
From Jul 2023 to Jul 2024 Click Here for more Adolor Corp. (MM) Charts.