Tris Pharma Expands ADHD Portfolio with Acquisition of NextWave Pharmaceuticals
Tris ADHD Franchise Includes Quillivant XR (methylphenidate HCl), QuilliChew ER (methylphenidate HCl) and DYANAVEL XR (amphetamine) Offering Multiple Treatment Options for Children and Adolescents with ADHD
MONMOUTH JUNCTION, NJ,? - Tris Pharma, Inc. (Tris), a? pharmaceutical company focused on developing innovative technology-based therapeutic products that address unmet patient needs, today announced the acquisition of NextWave Pharmaceuticals (NextWave), a wholly owned subsidiary of Pfizer Inc. (Pfizer), including two key Attention Deficit Hyperactivity Disorder (ADHD) treatments. The acquisition further expands Tris? portfolio of products for the treatment of patients with ADHD. The agreement includes the acquisition of Quillivant XR, the first and only marketed extended-release oral liquid methylphenidate, and QuilliChew ER, the first and only extended-release methylphenidate chewable tablet, both of which are central nervous system (CNS) stimulants approved for the treatment of ADHD. Please see important safety information for Quillivant XR and QuilliChew ER, including Boxed Warning about Abuse and Dependence, below. Quillivant XR and QuilliChew ER were co-developed by NextWave and Tris, utilizing Tris? novel, proprietary LiquiXR ? platform. In 2012, Pfizer acquired NextWave, and Tris continued to manufacture both products for Pfizer, prior to and after US Food and Drug Administration (FDA) approval. ?As co-developer of Quillivant XR and QuilliChew ER, we are excited to bring commercialization of these products in house and expand our ADHD portfolio,??said Ketan Mehta, President and Chief Executive Officer, Tris. ?To further support our newest acquisition, Tris is expanding our commercial footprint and building a world class medical affairs group.? ?Our newest acquisition brings us one step closer to realizing our corporate mission, to develop and expand offerings to meet unmet needs for all patients?, said Barry K. Herman, M.D., M.M.M., Tris? Chief Medical Officer. ?With three treatment options for patients with ADHD, Tris now offers a broad, established product portfolio with both stimulant classes in the ADHD space.? DYANAVEL XR is the first liquid amphetamine for children 6 years and older with ADHD, launched by Tris in 2016. Please see important safety information for DYANAVEL XR, including Boxed Warning about Abuse and Dependence, below. Important Safety Information for Quillivant XR and QuilliChew ER Quillivant XR and QuilliChew ER are federally controlled substances (CII) because they can be abused or lead to dependence. Keep Quillivant XR and QuilliChew ER in a safe place to prevent misuse and abuse. Selling or giving away Quillivant XR or QuilliChew ER 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 or QuilliChew ER should not be taken if you or your child?are allergic to methylphenidate hydrochloride, or any of the ingredients in Quillivant XR or QuilliChew ER, or are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI. The following have been reported with the use of methylphenidate hydrochloride and other stimulant medicines:- Heart-related problems:
- Sudden death in patients who have heart problems or heart defects
- Stroke and heart attack in adults
- Increased blood pressure and heart rate
- Your healthcare provider should check you or your child?s blood pressure and heart rate regularly during treatment with Quillivant XR or QuilliChew ER
- Mental (psychiatric) problems:
- New or worse behavior and thought problems
- New or worse bipolar illness
- May cause new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
- Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud?s phenomenon):
- Fingers or toes may feel numb, cool, painful, or may change color from pale, to blue, to red
- Heart-related symptoms such as chest pain, shortness of breath, or fainting
- New or worsening mental (psychiatric) symptoms or new manic symptoms
- Signs of unexplained wounds appearing on fingers or toes?while taking Quillivant?XR or QuilliChew ER
- You or your child have, or have a family history of, 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, are suspicious), mania, bipolar illness, or depression, or a family history of suicide, bipolar illness, or depression
- You or your child have circulation problems in fingers and toes
- You or your child have phenylketonuria (PKU). QuilliChew ER contains phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU or who are allergic to phenylalanine
- You are pregnant or plan to become pregnant. It is not known if Quillivant XR or QuilliChew ER will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant
- You are breastfeeding or plan to breastfeed. Quillivant XR or QuilliChew ER passes into your breast milk. You and your doctor should decide if you will take Quillivant XR or QuilliChew ER or breastfeed
- See ?What is the most important information I should know about Quillivant XR or QuilliChew ER???for information on reported heart and mental problems.
- Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism seek medical help right away.?Because priapism can cause long-lasting damage, it should be checked by a healthcare provider right away
- Slowing of growth (height and weight) in children
- Decreased appetite
- Trouble sleeping
- Nausea
- Vomiting
- Indigestion
- Stomach pain
- Weight loss
- Anxiety
- Dizziness
- Irritability
- Mood swings
- Fast heart beat
- Increased blood pressure
- if you or your child have heart problems or heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in children and adolescents with heart problems or defects, and sudden death, stroke, and heart attack have happened in adults. Your doctor should check you or your child carefully for heart problems before starting DYANAVEL?XR. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment.?Call the doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking DYANAVEL?XR.
- if you or your child have mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
- if you or your child have circulation problems in fingers and toes (called peripheral vasculopathy, including Raynaud?s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature, and/or change color from pale, to blue, to red.?Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking DYANAVEL?XR.
- if your child is having slowing of growth (height and weight); DYANAVEL?XR may cause this serious side effect. Your child should have his or her height and weight checked often while taking DYANAVEL?XR. The doctor may stop treatment if a problem is found during these check-ups.
- if you or your child are pregnant, breastfeeding, or plan to become pregnant or breastfeed.
- Dry mouth
- Decreased appetite
- Weight loss
- Stomach pain
- Nausea
- Trouble sleeping
- Restlessness
- Extreme mood changes
- Dizziness
- Increase heart rate