NextWave Pharmaceuticals Receives FDA Approval of Quillivant XR(TM) for Once-Daily Treatment of ADHD
CUPERTINO, Calif. — NextWave Pharmaceuticals, an emerging specialty pharmaceutical company, announced FDA approval of Quillivant XR((TM)) (methylphenidate hydrochloride) for extended-release oral suspension, CII. Quillivant XR is approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Quillivant XR is the first once-daily, extended-release liquid methylphenidate available for patients with ADHD.
"The approval of Quillivant XR fills a void that has long existed in the treatment of ADHD," said Ann Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine, Las Vegas, who was an investigator in the Quillivant XR laboratory classroom study. "We routinely see the struggles of patients who have difficulty swallowing pills or capsules. Having the option of a once-daily liquid will help alleviate some of these issues while still providing the proven efficacy of methylphenidate for 12 hours after dosing."
The efficacy of Quillivant XR was evaluated in a randomized, double-blind, placebo-controlled, crossover, multicenter, laboratory classroom study of 45 children with ADHD. There was an open-label dose optimization period (four to six weeks) with an initial 20mg dose of Quillivant XR once daily in the morning. The dose was titrated weekly in 10 or 20mg increments until an optimal dose or maximum dose of 60mg per day was reached. Patients then entered a two-week double-blind, crossover treatment of the individually optimized dose of Quillivant XR or placebo.
At the end of each week, trained observers evaluated the attention and behavior of the patients in a laboratory classroom using the SKAMP (Swanson, Kotkin, Agler, M-Flynn and Pelham) rating scale. Quillivant XR significantly improved ADHD symptoms compared to placebo at the primary endpoint of four hours post-dose, and in a secondary analysis, showed significant improvement at every time point measured, from 45 minutes to 12 hours after dosing.
"We are pleased with the FDA's approval of Quillivant XR and believe it will address an important need for many patients with ADHD and their caregivers," said Jay Shepard, President and CEO of NextWave Pharmaceuticals. "We are eager to enter into the ADHD market and believe the unique liquid formulation of Quillivant XR — which was developed in conjunction with NextWave's technology and manufacturing partner Tris Pharma — will provide another treatment option for patients with ADHD."
Quillivant XR is expected to become available in pharmacies in January 2013. Quillivant XR was developed using Tris Pharma's patent protected drug delivery platform.
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About Quillivant XR
IMPORTANT SAFETY INFORMATION
Quillivant XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Quillivant XR in a safe place to prevent misuse and abuse. Selling or giving away Quillivant XR may harm others and is against the law.
Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Quillivant XR should not be taken if you or your child are allergic to methylphenidate hydrochloride, or any of the ingredients in Quillivant XR, or are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.
Heart-related problems have been reported with CNS stimulant medications:
Sudden death in patients who have heart problems or heart defects
Stroke and heart attack in adults
Increased blood pressure and heart rate
Mental (psychiatric) problems can be caused or worsened by CNS stimulant medications:
New or worsening bipolar symptoms
New or worsening psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious)
Call your doctor right away if you or your child have any heart-related symptoms or new or worsening mental (psychiatric) symptoms while taking Quillivant XR.
Quillivant XR may not be right for you. Tell your doctor if:
You or your child has heart problems, heart defects, or high blood pressure
You or your child have mental problems including psychosis (hearing voices, believing things that are not true, suspicious), mania, bipolar illness, or depression
You are pregnant or plan to become pregnant. It is not known if Quillivant XR will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant
You are breastfeeding or plan to breast feed. Quillivant XR passes into your breast milk. You and your doctor should decide if you will take Quillivant XR or breast feed
Possible serious side effects of Quillivant XR are heart-related problems and mental problems, as well as slowing of growth (height and weight) in children.
Common side effects include:
Decreased appetiteWeight VomitingTrouble sleeping Mood swings Blurred visionIncreased blood
lossNauseaStomach pain Dry AnxietyNervousnessRestlessness AgitationIrritabilityDizzinessShaking pressureFast heart beatIncreased
mouth (tremor) sweatingFever
Talk to your doctor if you or your child has side effects that are bothersome or do not go away.
This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.
Quillivant XR is a central nervous system (CNS) stimulant prescription medicine. Quillivant XR is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Quillivant XR may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Please see full Prescribing Information and Medication Guide, including BOXED WARNING regarding Abuse and Dependence, at www.quillivantxr.com/PI.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
About Attention Deficit Hyperactivity Disorder (ADHD)
ADHD is one of the most common neurobehavioral disorders in the United States. According to the Centers for Disease Control and Prevention (CDC) 2009 report, almost one in ten (9.5 percent) children aged 4-17 in the U.S. have at some time received a diagnosis of ADHD.(1) The condition often lasts into adulthood with adult ADHD affecting an estimated 4 percent of Americans.(2) ADHD is characterized by symptoms that include difficulty paying attention, impulsive behaviors and in some cases patients being overly active.(3)
About NextWave Pharmaceuticals
NextWave is an emerging specialty pharmaceutical company focused on the development and commercialization of unique products for the treatment of ADHD and related CNS disorders. More information about NextWave is available at www.nextwavepharma.com.
About Tris Pharma
Tris Pharma is a specialty pharmaceutical company focused on the research and development of drug delivery technologies based products. Through its proprietary formulation technology, Tris has developed extended-release liquid, chewable/ODT and strip dosage forms so patients do not have to swallow a pill. Tris' research, development, and manufacturing facilities are located in Monmouth Junction, New Jersey. More information about Tris is available at www.trispharma.com.
Centers for Disease Control and Prevention. Increasing prevalence of parent-reported attention deficit/hyperactivity disorder among children – United States, 2003 and 2007. MMWR. 2010;59(44):1439-43.
Kessler RC, Adler L, Barkley R, et al. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry. 2006;163(4):716-23.
American Psychiatric Association. Diagnostic and statistical manual of mental disorders: dsm-iv-tr. Washington: American Psychiatric Association; 2000.
Quillivant XR((TM)) is a trademark of NextWave Pharmaceuticals, Inc.
© 2012 NextWave Pharmaceuticals, Inc. Cupertino, CA.
SOURCE NextWave Pharmaceuticals