Alpharma Announces Positive Results From Pivotal Phase III Efficacy Trial on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules at the American Academy of Pain Management Annual Clinical Meeting
BRIDGEWATER, N.J., September 09, 2008 /PRNewswire-FirstCall/ -- Alpharma Inc. , a global specialty pharmaceutical company, today announced results from its Phase III pivotal efficacy trial that showed ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) capsules provided significant pain relief in patients with moderate to severe pain due to osteoarthritis of the hip or knee compared to placebo. Findings also showed that ALO-01 capsules were safe and well-tolerated. This study was presented in a poster session at the 19th Annual Clinical Meeting of the American Academy of Pain Management in Nashville.
ALO-01 is an investigational pharmacologic abuse-deterrent, extended-release opioid that Alpharma is developing for the treatment of moderate to severe chronic pain. Utilizing Alpharma's proprietary technology, ALO-01 capsules combine an extended-release opioid, morphine sulfate, with a sequestered core of naltrexone, an opioid antagonist. When ALO-01 capsules are taken as directed, the naltrexone passes through the body without clinically meaningful release or accumulation.
According to the study findings, patients who were taking ALO-01 capsules reported significantly more effective pain relief, as measured by mean change in the weekly Brief Pain Inventory (BPI) Average Pain Intensity Score from baseline to the 12-week endpoint of the study, compared to patients who were taking placebo. Additionally, 72.5 percent of patients reported taking ALO-01 experienced pain relief of at least 30 percent from baseline, compared to 57.8 percent patients given placebo.
"These results are very exciting as we believe they demonstrate that ALO-01 has the potential to bring clear clinical benefit to pain patients while delivering peace of mind to physicians and pharmacists," said Joseph Stauffer, D.O., Chief Medical Officer, Senior Vice President of Clinical Research & Medical Affairs, Alpharma Pharmaceuticals. "We look forward to collaborating with the FDA during the review process for ALO-01, which, if approved, would be the first opioid medicine to provide a pharmacologic abuse-deterrent feature while effectively treating patients with chronic pain."
On September 2nd, Alpharma announced that the United States Food and Drug Administration ("FDA") had accepted its New Drug Application ("NDA") for ALO-01 capsules for priority review. The priority review status provides for a review period of six months from the date of submission. The ALO-01 capsule NDA was submitted on June 30, 2008.
In the United States, pain is a serious, undertreated public health problem, with 19 percent of American adults reporting chronic pain and 34 percent reporting recurrent pain.(1A) Opioids provide effective pain management and are especially useful in treating appropriately selected patients with moderate to severe chronic pain who have not responded adequately to other pain management therapies.(2,3A) However, prescription opioid abuse has escalated along with increased legitimate use in pain management.(1B,4A,5) In fact, 70 percent of people who have abused opioids got them from friends and relatives (by stealing, buying, or receiving them).(6) Because of potential prescription opioid abuse, patients and physicians may be reluctant to initiate opioid therapy for pain relief.(4B) Therefore, there is a need for products that deliver effective pain relief while minimizing the potential for misuse, abuse and diversion.(3B,7)
The 12-week, double-blind, randomized, placebo-controlled enriched enrollment Phase III pivotal trial assessed the effectiveness of ALO-01 capsules when compared with placebo in 344 adult patients with moderate to severe pain due to osteoarthritis of the hip or knee. After a screening and washout period from previous treatments (less than or equal to 14 days), patients were administered two periods of treatment with study drugs. Patients were first titrated to effective pain management levels with ALO-01 capsules during open label titration, they were then randomized to double-blind treatment with either ALO-01 capsules or placebo for 12 weeks. Study participants were allowed to use acetaminophen as a rescue medication, up to 500 mg every six hours, as needed.
Efficacy assessments included pain intensity scores on the BPI, recorded in a subject diary and assessed at in-clinic visits.
Safety and tolerability included measurements by rates of self-reported adverse events and a measure of opioid withdrawal, an indication of naltrexone leakage from the capsules, called clinical opiate withdrawal scores (COWS). ALO-01 capsules were safe and well-tolerated in this study, with an overall safety profile consistent with that of other opioid products. COWS data suggest that naltrexone did not leak out of the capsules, and there was no increased risk of opioid withdrawal versus placebo. Adverse events were mostly mild to moderate. The most common adverse events during titration with ALO-01 were constipation (30.5 percent) and nausea (21.0 percent); during the 12-week maintenance phase the adverse events were diarrhea (12.3 percent and 12.1 percent) and nausea (11.7 percent and 7.5 percent) for ALO-01 and placebo groups, respectively.
Statements made in this release include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including those relating to future financial expectations, involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Information on other important potential risks and uncertainties not discussed herein may be found in the Company's filings with the Securities and Exchange Commission including its Form 10-K for the year ended December 31, 2007.
Alpharma Inc. is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Alpharma is presently active in more than 80 countries. Alpharma has a growing branded pharmaceutical franchise in the U.S. pain market with its KADIAN(R) (morphine sulfate extended-release) Capsules, and the FLECTOR(R) Patch (diclofenac epolamine topical patch). In addition, Alpharma is internationally recognized as a leading provider of pharmaceutical products for poultry and livestock.
Alpharma press releases are also available at our website, www.alpharma.com.
Contact: Jack Howarth Vice President, Investor Relations 908-566-4153 Jack.email@example.com
1. Kuehn BM. Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA. 2007; 297:249-251.
2. Katz NP, Adams EH, Chilcoat H, et al. Challenges in the development of prescription opioid abuse-deterrent formulations. Clin J Pain. 2007; 23:648-660.
3. Woolf CJ, Hashmi M. Use and abuse of opioid analgesics: potential methods to prevent and deter non-medical consumption of prescription opioids. Curr Opin Invest Drugs. 2004; 5:61-66.
4. Gagnon AM, Kahan M, Srivastava A. Opioid use and abuse: is there a problem? Clin J Pain. 2007; 23:661-662.
5. Birnbaum HG, Whiate AG, Reynolds JL, et al. Estimated costs of prescription opioid analgesic abuse in the United States in 2001: a societal perspective. Clin J Pain. 2006; 22:667-676.
6. Substance Abuse and Mental Health Services Administration. (2007). Results from the 2006 National Survey on Drug Use and Health: National Findings (Office of Applied Studies, NSDUH Series H-32, DHHS Publication No. SMA 07-4293). Rockville, MD.
7. Wright C, Kramer ED, Zalman MA, et al. Risk identification, risk assessment, and risk management of abusable drug formulations. Drug Alcohol Depend. 2006; 83(Supp 1):S68-S76.
CONTACT: Jack Howarth, Vice President, Investor Relations, Alpharma Inc.,+1-908-566-4153, Jack.firstname.lastname@example.org
Web site: http://www.alpharma.com/
Ticker Symbol: (NYSE:ALO)
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Posted: September 2008