ALISO VIEJO, Calif., April 15, 2016 /PRNewswire/ -- Furthering its commitment to developing treatments for central nervous system disorders, Avanir Pharmaceuticals, Inc. today announced that data from the PRISM II study of NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules for the treatment of pseudobulbar affect (PBA) and multiple data presentations on the use of ONZETRA™ Xsail™ (formerly AVP-825), which was approved by the FDA in January for the acute treatment of migraine with or without aura in adults, will be presented at the 68th American Academy of Neurology (AAN) Annual Meeting being held April 15-21 in Vancouver, British Columbia, Canada.
- "PRISM II: Effectiveness of Dextromethorphan 20 Mg/Quinidine 10 Mg (NUEDEXTA®) for Treatment of Pseudobulbar Affect Secondary to Dementia, Stroke, or Traumatic Brain Injury: Combined Results of a Multicenter Open-Label Study" will be presented by Dr. Flora Hammond of Indiana University School of Medicine on Sunday, April 17 from 4-5:30 p.m. PT in Poster Session 2. Poster P2.225.
ONZETRA Xsail (formerly AVP-825) Presentations
- "Total Migraine Freedom for Breath Powered Intranasal Delivery System Containing 22 Mg Sumatriptan Powder (AVP-825) vs. 100 Mg Oral Sumatriptan from the COMPASS Study of Acute Treatment of Migraine" will be presented by Dr. Stewart Tepper of the Dartmouth School of Medicine on Sunday, April 17 from 3-3:30 p.m. PT in the Guided Poster Rounds and Thursday, April 21 from 4-5:30 p.m. PT in Poster Session 6. Abstract I3.009 and P6.098.
- "Reduced Treatment-Emergent Nausea Using AVP-825 vs. Sumatriptan Tablets: A Comparative Effectiveness Study" will be presented by Dr. Kenneth Shulman of Avanir Pharmaceuticals on Sunday, April 17 from 4-5:30 p.m. PT in Poster Session 2. Poster P2.215.
- "AVP-825 Reduces Nausea Faster Than Sumatriptan Tablets: A Comparative Effectiveness Study" will be presented by Dr. James McGinley of Vector Psychometric Group on Sunday, April 17 from 4-5:30 p.m. PT in Poster Session 2. Poster P2.217.
- "Rapid Response in Migraine Patients Treated with Breath Powered Intranasal Delivery of Sumatriptan Powder (AVP-825): Efficacy Analysis by Prior Triptan History from the Phase 3 TARGET Study" will be presented by Dr. Kenneth Shulman of Avanir Pharmaceuticals on Thursday, April 21 from 4-5:30 p.m. PT in Poster Session 6. Poster P6.102.
- "A Low Incidence of Atypical Sensations with AVP-825 (Breath Powered Intranasal Delivery System Containing 22 Mg Sumatriptan Powder) Migraine Therapy Across Multiple Phase 2/3 Clinical Trials" will be presented by Dr. Kenneth Shulman of Avanir Pharmaceuticals on Thursday, April 21 from 4-5:30 p.m. PT in Poster Session 6. Poster P6.106.
Avanir Pharmaceuticals will be exhibiting at the meeting in Booth #1201.
NUEDEXTA is an innovative combination of two well-characterized components, dextromethorphan hydrobromide, the ingredient active in the central nervous system, and quinidine sulfate, a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. Dextromethorphan acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.
NUEDEXTA Important Safety Information
NUEDEXTA is indicated for the treatment of PBA. PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of crying and/or laughing. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.
NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules 20 mg/10 mg can interact with other medications, including those metabolized by CYP2D6, causing significant changes in blood levels of those medications and/or NUEDEXTA which may lead to serious side effects. Adjust dose of the other medication or use alternate treatment when clinically indicated.
NUEDEXTA is contraindicated in patients concomitantly taking: QT-prolonging drugs metabolized by CYP2D6 (e.g., thioridazine and pimozide); monoamine oxidase inhibitors (MAOIs) within the preceding or following 14 days; other drugs containing quinidine, quinine, or mefloquine and in patients with a known hypersensitivity (including prior quinidine-induced thrombocytopenia, hepatitis, bone-marrow depression, or lupus-like syndrome) to these drugs or any of NUEDEXTA's components.
NUEDEXTA is contraindicated in patients with certain risk factors for arrhythmia such as: Prolonged QT interval; congenital long QT syndrome, history suggestive of torsades de pointes; heart failure; complete atrioventricular (AV) block or risk of AV block without an implanted pacemaker.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation should be conducted at baseline and 3-4 hours after the first dose. Risk factors include left ventricular hypertrophy or dystrophy or concomitant use of drugs that prolong QT interval or concurrent use of moderate to strong CYP3A4 inhibitors.
Quinidine can cause immune-mediated thrombocytopenia that can be severe or fatal. Discontinue use of NUEDEXTA if thrombocytopenia, hepatitis, serotonin syndrome or a hypersensitivity reaction occurs. Anticholinergic effects have been reported in patients taking quinidine. Monitor for worsening in myasthenia gravis.
NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.
The most common adverse reactions are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence.
These are not all the risks from use of NUEDEXTA.
Please refer to the Full Prescribing Information or visit www.NUEDEXTA.com.
About ONZETRA Xsail
ONZETRA Xsail is an intranasal medication delivery system consisting of sumatriptan powder, the most commonly prescribed migraine medication. The medication is delivered intranasally utilizing the novel Xsail Breath Powered® delivery technology. ONZETRA Xsail is a fast-acting dry-powder intranasal form of sumatriptan for the acute treatment of migraine. Sumatriptan is the most widely used prescription migraine medication and has been used safely for over 20 years. Sumatriptan is contraindicated for certain patients, including those with a history of coronary artery disease (CAD) or coronary vasospasm.
The Breath Powered delivery technology relies on the user's breath to propel medication into the nasal cavity where absorption is efficient and consistent. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. Narrow nasal passages are gently expanded and medication is dispersed into the nasal cavity reaching areas where it can be rapidly absorbed. As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing and reduce GI absorption.
ONZETRA Xsail Important Safety Information
ONZETRA Xsail is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
- Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with ONZETRA Xsail, reconsider the diagnosis of migraine before treatment of subsequent attacks with ONZETRA Xsail.
- ONZETRA Xsail is not indicated for the prevention of migraine attacks.
- Safety and effectiveness of ONZETRA Xsail have not been established for the treatment of cluster headache.
ONZETRA Xsail is contraindicated in patients with:
- Ischemic coronary artery disease (CAD) or coronary artery vasospasm, including Prinzmetal's angina; or Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
- History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine; peripheral vascular disease; ischemic bowel disease; or uncontrolled hypertension
- Recent (i.e., within 24 hours) use of ergotamine-containing or ergot-type medication, or another 5-HT1 agonist; or concurrent or recent (within 2 weeks) use of a MAO-A inhibitor
- Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) or severe hepatic impairment
Other serious adverse events associated with the use of sumatriptan or 5-HT1 agonists include: myocardial ischemia/infarction, Prinzmetal's angina, arrhythmias; chest, throat, neck and/or jaw pain/tightness/pressure; cerebral hemorrhage, subarachnoid hemorrhage, and stroke; peripheral vascular ischemia, gastrointestinal vascular ischemia/infarction, and Raynaud's syndrome, medication overuse headache; serotonin syndrome; significant elevation in blood pressure; anaphylactic/anaphylactoid reactions; and seizures.
In clinical trials, the most common adverse reactions (≥ 2% and > placebo) were abnormal taste, nasal discomfort, rhinorrhea, and rhinitis.
Advise patients to carefully read the Patient Information and Instructions for Use prior to using ONZETRA Xsail.
For additional important safety information about ONZETRA Xsail, please see Full Prescribing Information or visit www.ONZETRA.com.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit http://www.avanir.com.
Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd., a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.'
Otsuka researches, develops, manufactures and markets innovative and original pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does. Otsuka Pharmaceutical and related companies, employ approximately 31,000 people worldwide. You can visit the company's global website at https://www.otsuka.co.jp/en.
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SOURCE Avanir Pharmaceuticals, Inc.