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Tris Pharma
Announces Continued Supply and Availability of
DYANAVEL
® XR (amphetamine) Tablets and Oral Suspension for
ADHD
Despite Adderall shortage
2022-10-19
·
BioSpace
Once daily extended release provides early onset and full day coverage MONMOUTH JUNCTION, N.J., Oct. 19, 2022 /PRNewswire/ --
Tris Pharma, Inc.
(Tris) a fully integrated pharmaceutical company with a robust portfolio of CNS products announced today that
DYANAVEL
® XR (amphetamine) extended-release tablets, for oral use, CII and
DYANAVEL
® XR (amphetamine) extended-release oral suspension, CII are stocked by wholesalers and continue to be available in pharmacies.
DYANAVEL XR
was approved by the
U.S. Food and Drug Administration
for the treatment of Attention-
Deficit Hyperactivity Disorder (ADHD)
in patients 6 years and older.
Dyanavel XR
may be an option for health care providers and patients who can no longer fill their prescription of
Adderall
due to a stocking shortage. In a double-blind, placebo-controlled, fixed-dose Phase 3 study in adults with
ADHD
,
DYANAVEL XR
tablets demonstrated statistically significant improvement versus placebo in mean Permanent Product Measure of Performance Total (PERMP-T) scores averaged across all measured post-dose time points (0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours post-dose). The PERMP-T is a validated and FDA-accepted, skill-adjusted, timed math test that is used to assess attention in people with
ADHD
. The most common adverse events included
headache
,
decreased appetite
,
irritability
, initial
insomnia
,
insomnia
,
dry mouth
,
anxiety
,
dizziness
,
tachycardia
,
fatigue
, and
nausea
. Most treatment-emergent AEs (TEAEs) were mild to moderate in severity, and no SAEs were reported during the study. These finds were recently published in The Journal of Clinical Psychiatry (Cutler, et al. J Clin Psychiatry 2022. 83(00):22m14438). In another clinical study in healthy adults,
DYANAVEL XR
extended-release tablets were deemed to be bioequivalent to
DYANAVEL XR (amphetamine)
extended-release oral suspension CII, which in a Phase 3 clinical study of children aged 6 to 12 years with
ADHD
, demonstrated
ADHD
symptom improvement within 1 hour, that lasted through 13 hours after once-daily dosing. "With the Innovative Tris portfolio of
ADHD
products, we are committed to help Providers and Patients through their treatment journey.
DYANAVEL XR
Tablet and
DYANAVEL XR
oral suspension provide quality treatment options for adult and pediatric patients 6 years and older with
ADHD
who need an
amphetamine
", said Dr. James Hackworth, President of the Tris Branded Products Division.
DYANAVEL XR
is a federally controlled substance (CII) because it contains
amphetamine
that can be a target for people who abuse prescription medicines or street drugs. Keep
DYANAVEL XR
in a safe place to protect it from theft. Never give your
DYANAVEL XR
to anyone else because it may cause death or harm them. Selling or giving away
DYANAVEL XR
may harm others and is against the law. See additional important safety information below. About
Tris Pharma
Tris is a fully integrated, innovation-driven CNS company that provides a differentiated approach to target unmet medical needs, including the application of novel technologies designed to enhance patient benefits across therapeutic categories. Tris's CNS portfolio includes treatments for
pain
; addiction;
spasticity
in
multiple sclerosis
,
cerebral palsy
;
narcolepsy
; and
ADHD
. For more information, please visit and . APPROVED USE
DYANAVEL XR
is a central nervous system (CNS) stimulant prescription medicine used for the treatment of
Attention Deficit Hyperactivity Disorder (ADHD)
in people 6 years and older.
DYANAVEL XR
may help increase attention and decrease impulsiveness and hyperactivity in people with
ADHD
. It is not known if
DYANAVEL XR
is safe and effective in children under 6 years of age. IMPORTANT SAFETY INFORMATION
DYANAVEL XR
is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep
DYANAVEL XR
in a safe place to prevent misuse and abuse. Selling or giving away
DYANAVEL XR
may harm others and is against the law. Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
DYANAVEL XR
should not be taken if you or your child are allergic to
amphetamine
or any of the ingredients in
DYANAVEL XR
or are taking or have taken within the past 14 days an anti-
depression
medicine called a
monoamine oxidase inhibitor
monoamine oxidase
inhibitor or MAOI.
DYANAVEL XR
can cause serious side effects. Tell the doctor: if you or your child have
heart problems
,
heart defects
, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in children 6 to 17 years old 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); Your child should have his or her height and weight checked often while taking
DYANAVEL XR
. if you or your child have symptoms of
serotonin syndrome
-
agitation
,
hallucinations
,
coma
, or other changes in mental status; fast heartbeat; sweating or
fever
;
nausea
,
vomiting
,
diarrhea
; high or low blood pressure; problems controlling movements or muscle twitching; muscle stiffness or tightness.
Serotonin syndrome
may occur when
DYANAVEL XR
is taken with certain other medicines and may be life-threatening. Stop
DYANAVEL XR
and call your doctor or go to the nearest hospital emergency room. if you or your child are pregnant or plan to become pregnant. It is not known if
DYANAVEL XR
will harm your unborn baby. Tell your doctor if you or your child become pregnant during treatment with
DYANAVEL XR
. if you or your child is breastfeeding or plan to breastfeed.
DYANAVEL XR
passes into breast milk. You or your child should not breastfeed while you are taking
DYANAVEL XR
. Common side effects of amphetamine products include: Talk to your doctor if you or your child have any side effects that bother you or do not go away. Avoid drinking alcohol while taking
DYANAVEL XR
. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see Full Prescribing Information, including Boxed Warning about Abuse and Dependence, and Medication Guide. References Cutler AJ, Childress AC, Pardo A, et al. Randomized, double-blind, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of amphetamine extended-release tablets in adults with
attention-deficit/hyperactivity disorder
. J Clin Psychiatry. 2022; 83(00):22m14438. doi:10.4088/JCP.22m14438 Pardo A, Kando JC, King TR, Rafla E, Herman BK. Single-dose pharmacokinetics of amphetamine extended-release tablets compared with amphetamine extended-release oral suspension. CNS Spectr. 2020;25(6):774-781. doi:10.1017/S1092852919001676
DYANAVEL
® and LiquiXR® are registered trademarks of
Tris Pharma, Inc.
©2022
Tris Pharma, Inc.
All rights reserved.
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机构
Tris Pharma, Inc.
US Food & Drug Administration
适应症
发作性睡病
疼痛
焦虑
[+31]
靶点
MAO
药物
苯丙胺
Amphetamine/Amphetamine Aspartate/Dextroamphetamine Sulfate
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate
[+1]
标准版
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16800
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