— Pharmacokinetic Data Supporting Phase 3 Development of ALKS 9070, a Long-Acting Injectable Antipsychotic, to be Presented at the Annual Meeting of the
— Phase 1/2 Data of Novel Depression Drug Candidate, ALKS 5461, Will Also be Highlighted at ACNP —
— Clinical and Pharmacoeconomic Analyses of VIVITROL® in the Treatment of Alcohol and Opioid Dependence to be Presented at the
At the
Key presentations for these two medical meetings include:
ACNP
The oral presentation, "New Clinical Research in Opioid Modulation Indicates Novel Utility in Treating Resistant Depression" will be given by
Poster 18: "ALKS 5461, a Novel Opioid Receptor Modulator, Reduces the Subjective Effects of Cocaine and was Safe and Well Tolerated During Concurrent Cocaine Administration" will be presented by
Poster 173: "ALKS 5461, a Novel Opioid Receptor Modulator, Normalizes Human EEG Responses in an
Poster 174: "Pharmacokinetic Modeling of ALKS 9070 (ALKS 9072), a Novel Once-Monthly Prodrug of Aripiprazole" will be presented by
Further details on the ACNP Annual Meeting are available at: www.acnp.org/annualmeeting.
AAAP
"Medication and Non-Medication Treatment of Alcohol Dependence: A NNT (Number Needed to Treat) Analysis" will be presented by
"Extended-Release Naltrexone (XR-NTX) in Inpatient Rehab Post-Detox: Retention, Readmission, Clinical Experience and Impact on Managed Care" will be presented by
"Cost-Effectiveness of Treatment with Extended-Release Naltrexone: A Meta-Analysis Across Five Studies" will be presented by
"Extended-Release Injectable Naltrexone (XR-NTX) for Opioid Dependence: Efficacy in Depressed Patients and Other Clinically Relevant Subpopulations" will be presented by
Further details on the AAAP Annual Meeting are available at: www.aaap.org/meetings-and-events/2012-annual-meeting.
About ALKS 9070 and LinkeRx®
LinkeRx is a novel, proprietary technology platform developed by
About ALKS 5461
ALKS 5461 is the combination of ALKS 33 and buprenorphine and is designed to be a non-addictive opioid modulator. ALKS 33 is an oral opioid modulator that builds on Alkermes' scientific expertise in opioid biology and pharmacology, as well as the company's clinical and commercial knowledge in the field of addiction and CNS disorders. ALKS 5461 is in clinical development for the treatment of MDD in patients who have an inadequate response to standard therapies for clinical depression, as well as for the treatment of cocaine dependence, which is being funded through a grant from the
About VIVITROL
VIVITROL (naltrexone for extended-release injectable suspension) 380 mg/vial is the first and only once-monthly, extended-release injectable medication for the treatment of alcohol dependence and opioid dependence. The proprietary Medisorb® drug delivery technology in VIVITROL enables the medication to be gradually released into the body at a controlled rate over a one-month time period. Treatment with VIVITROL should be part of a comprehensive treatment program that includes psychosocial support. VIVITROL has been studied in more than 1,000 patients and has been used to treat more than 45,000 people for alcohol and opioid dependence in the U.S. The VIVITROL clinical development program was funded in part with a
Important Safety Information for VIVITROL® (naltrexone for extended-release injectable suspension) 380 mg/vial.
WARNING: HEPATOTOXICITY
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.
CONTRAINDICATIONS
VIVITROL is contraindicated in patients with acute hepatitis or liver failure, patients receiving opioid analgesics, patients with current physiologic opioid dependence, patients in acute opioid withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, and in patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose or any other components of the diluent.
WARNINGS/PRECAUTIONS
• Injection Site Reactions: VIVITROL is administered as an intramuscular (IM) gluteal injection. Inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions. VIVITROL must be injected using one of the customized needles 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 IM administration. VIVITROL injections 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.
• Eosinophilic Pneumonia: VIVITROL patients should be warned of the risk of eosinophilic pneumonia, and advised to seek medical attention should they develop symptoms of pneumonia.
• Hypersensitivity Reactions Including Anaphylaxis: Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis.
• Unintended Precipitation of Opioid Withdrawal: Opioid-dependent and opioid-using patients, including those being treated for alcohol dependence, must be opioid-free for a minimum of 7-10 days before starting VIVITROL treatment.
• Opioid Overdose at the End of a Dosing Interval, After Missing a Dose and Following an Attempt to Overcome Opioid Blockade: Use of lower doses of opioids after VIVITROL treatment is discontinued, at the end of a dosing interval, or after missing a dose could result in life-threatening opioid intoxication. Any attempt by a patient to overcome the blockade produced by VIVITROL by taking opioids is very dangerous and may lead to fatal overdose.
• Depression and Suicidality: VIVITROL patients should be monitored for the development of depression or suicidal thinking.
• Intramuscular Injections: VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder.
• When Reversal of VIVITROL Blockade is Required for Pain Management: In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics.
ADVERSE EVENTS
The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders. The adverse events seen most frequently in association with VIVITROL in opioid-dependent patients include hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache.
About
Note Regarding Forward-Looking Statements
Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond the company's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements.
These risks and uncertainties include the risks described in the company's Annual Report on Form 10-K for the year ended
VIVITROL® and Medisorb® are registered trademarks of
Source:
Alkermes Contacts:
For Investors:
Rebecca Peterson, +1 781 609 6378
or
For Media:
Jennifer Snyder, +1 781 609 6166