— Once-Monthly, Non-Addictive Treatment Significantly Reduced Opioid Use in Multicenter, Six-Month Study —
— Company to File for FDA Approval in the First Half of Calendar 2010 —
In addition to meeting the primary efficacy endpoint, the six-month phase 3 study met all secondary efficacy endpoints. Data from the intent-to-treat (ITT) analysis show that the median patient taking XR-NTX had 90% opioid-free urine screens during the evaluation phase of the study and patients treated with XR-NTX demonstrated a significant reduction in opioid craving compared to placebo as measured by a visual analog scale. XR-NTX was generally well tolerated in the study and no patients on XR-NTX discontinued the study due to adverse events. The most common adverse events experienced by patients receiving XR-NTX during the study were nasopharyngitis and insomnia.
“These robust data show that XR-NTX helped opioid dependent patients
become drug-free with just one injection each month,” stated Dr.
“Medical treatment for opioid dependence is an established and growing
pharmaceutical market, yet there are limitations with currently
available therapies," stated Richard Pops, Chief Executive Officer of
Phase 3 Study Design
The phase 3 randomized, multi-center study was designed to assess the efficacy and safety of XR-NTX compared to placebo treatment in opioid dependent subjects who have been recently detoxified and abstinent from opioids for a minimum of seven days prior to treatment initiation. Two hundred and fifty subjects were randomized to receive once-monthly injections of either XR-NTX 380 mg or placebo in combination with counseling for six months. The primary efficacy endpoint was the response profile based on the rate of urine drug screens that were free of opioids during the last 20 weeks of the 24-week double-blind treatment period, as measured by the cumulative distribution of clean urine screens. The secondary efficacy endpoints in the phase 3 study were the study retention rate, craving scores, self-reported opioid use and the incidence of physiologic opioid dependence. All participants who completed the randomized portion of the study are eligible to continue in an open-label extension phase and receive XR-NTX once-monthly in combination with counseling for an additional thirteen months.
About Opioid Dependence
In addition to the use of heroin, an illegal opioid drug, opioid abuse
and addiction includes the non-medical use of
About VIVITROL
VIVITROL is the first and only once-monthly, extended-release injectable
medication for the treatment of alcohol dependence and was approved by
the
VIVITROL Important Safety Information in Alcohol Dependence
VIVITROL is contraindicated in patients receiving opioid analgesics or with current physiologic opioid dependence, patients in acute opiate withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, or in patients who have previously exhibited hypersensitivity to naltrexone PLG, carboxymethylcellulose or any other components of the diluent.
VIVITROL patients must be opioid free for a minimum of 7-10 days before treatment. Attempts to overcome opioid blockade due to VIVITROL may result in a fatal overdose. In prior opioid users, use of opioids after discontinuing VIVITROL may result in a fatal overdose because patients may be more sensitive to lower doses of opioids. Patients requiring reversal of the VIVITROL blockade for pain management should be monitored by appropriately trained personnel in a setting equipped for cardiopulmonary resuscitation.
Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.
Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.
The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses.
Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis.
VIVITROL is administered as a gluteal intramuscular injection. Inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions. VIVITROL must be injected using the customized needle provided in the carton. Because needle length may not be adequate due to body habitus, each patient should be assessed prior to each injection to assure that needle length is adequate for intramuscular administration. VIVITROL injection site reactions may be followed by pain, tenderness, induration, swelling, erythema, bruising or pruritus; however, in some cases injection site reactions may be very severe. Injection site reactions not improving may require prompt medical attention, including in some cases surgical intervention.
Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia. In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics. Alcohol dependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thoughts. Caution is recommended in administering VIVITROL to patients with moderate to severe renal impairment.
The most common adverse events associated with VIVITROL in clinical trials were nausea, vomiting, headache, dizziness, asthenic conditions and injection site reactions.
About
Certain statements set forth above may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to, the continued
development of XR-NTX for the treatment of opioid dependence; our plan
to file a sNDA for XR-NTX with
VIVITROL® and Medisorb® are registered trademarks
of
1SAMHSA,
2Birnbaum HG,
Source:
Alkermes, Inc.
For Investors:
Rebecca Peterson, 617-583-6378
or
For
Media:
Jennifer Snyder, 617-583-6166