Lindmik Research I FDA Releases Consumer Update on "ADHD Treatment and Response"
Click:190  Update time:2023-09-01  【Close


According to data from the National Institute of Mental Health in the United States, attention deficit/hyperactivity disorder, also known as ADHD, is a disease that typically begins between the ages of 3 and 6. This is not just a childhood disease. ADHD may persist into adolescence and into adulthood.


ADHD is divided into three types:


Millions of children diagnosed with ADHD


Research shows that the number of children diagnosed with ADHD continues to increase. According to data from the Centers for Disease Control and Prevention in the United States, as of 2019, approximately 10% of children aged 3 to 17 (6 million children) were diagnosed with ADHD.
Boys (13%) are more likely to be diagnosed with ADHD than girls (6%). Boys are also more likely to suffer from hyperactive impulsivity. This type of attention deficit hyperactivity disorder is more easily detected than quiet, inattentive children, "explained child psychiatrist Tiffany R. Falchioni, MD, who is reviewing the drug application process for treating attention deficit/hyperactivity disorder at the FDA.
If you suspect that your child may have ADHD, please consult your pediatrician or healthcare professional. Also check the child's vision, hearing, and other factors that may cause lack of concentration. Doctors may diagnose ADHD or refer your child to a mental health professional for evaluation.


Treatment of children with ADHD


The FDA has approved two types of drugs - stimulants and non stimulants - to help alleviate symptoms of ADHD and improve function in 6-year-old children.
Falchioni said that despite the name, stimulants (containing various forms of methylphenidate and amphetamines) have a sedative effect on children with ADHD. Stimulants are believed to increase levels of dopamine in the brain, a neurotransmitter related to motivation, attention, and movement.
The FDA has also approved four non stimulants for the treatment of ADHD symptoms: Strattera (10mg, 18mg, etc.), Intuniv (1mg, 2mg, 3mg, 4mg, etc.), Kappay (0.1mg, etc.), and Qelbree (100mg, 150mg, 200mg, etc.). Discuss with your healthcare professional which medications are most suitable for your child.
In addition to medication, some children with ADHD also receive behavioral therapy to help control symptoms and provide additional symptom control techniques. In addition, relevant parents can contact their children's schools and public welfare patient groups to obtain information and guidance on how to deal with ADHD.


The consequences of untreated ADHD


If left untreated, ADHD may have serious consequences. According to data from the American Society of Child and Adolescent Psychiatry, children may fall behind academically, encounter social difficulties, and have conflicts with their parents.
Research has shown that untreated children with ADHD visit emergency rooms more frequently and are more likely to experience self harm compared to those who receive treatment. Untreated ADHD adolescents (children aged 10 to 18) are more likely to take risks, such as drunk driving, and have twice as many motor vehicle accidents as those receiving treatment.


Test the effect of drugs on young children


Currently, FDA approved ADHD drugs on the market have been tested for safety and efficacy in clinical trials in children aged 6 and above. The FDA now requires children aged 4 and 5 to participate in clinical trials.
We know that ADHD drugs are prescribed for young children, and we believe that clinical research data must reflect the safety and efficacy of this age group, "Falchioni said.


Lindmik's viewpoint


The design of treatment drugs for young patients with ADHD needs to be coordinated with their daily life and learning scenarios. Therefore, currently, the drugs listed by the FDA are mostly multi specification and suitable for titration administration. The dosage forms are mainly oral sustained-release or transdermal preparations, as shown in the table below:


Representative varieties of ADHD medium and long-term stimulants

Drug name

Trade name

Pharmacological action time

Notes

Amphetamine sulfate

Dyanavel

8-12 hours

Oral solutions/liquids and tablets

Amphetamine sulfate

Evekeo

6 hours


Dexamphetamine

Dexedrine Spansule

6-8 hours


Dextroamphetamine and amphetamine

Adderall XR

8-12 hours


Dextroamphetamine and amphetamine

Mydayis

12 hours


Methylphenidate

Focalin XR

6-10 hours


Levamphetamine

Vyvanse

10-12 hours


Levamphetamine

Vyvanse chewable

10-12 hours

Chewable

Methylphenidate

Aptensio XR

10-12 hours


Methylphenidate

Concerta

8-12 hours


Methylphenidate

Cotempla XR ODT

8-12 hours

Soluble oral disintegrating tablets

Methylphenidate

Daytrana transdermal patch

Up to 10 hours

May cause skin irritation or discoloration

Methylphenidate

Metadate CD,Ritalin LA

8-10 hours


Methylphenidate

Metadate ER,Methylin ER

6-8 hours


Methylphenidate

Ritalin SR

4-8 hours


Methylphenidate

Quillichew ER

12 hours

Chewable

Methylphenidate

Quillivant XR

10-12 hours

Oral solution/liquid

D-Methylphenidate prodrug

/Methylphenidate

Azstarys

13 hours

Detachable capsules, take the contents and sprinkle them

Dexamphetamine

Xelstrym transdermal patch

Up to 12 hours

The pasting time is up to 9 hours and takes effect after 2 hours

Data source:WebMD


ADHD Non Doping Representative Variety

Drug name

Trade name

Pharmacological action time

Notes

Tomoxetine

Strattera

24 hours

Sleep problems, anxiety, fatigue, stomach discomfort, dizziness, dry mouth. Although rare, it can cause liver damage. Adults aged 18 to 24 have a higher risk of suicide.

Clonidine

Catapres

4-6 hours

Fatigue, dizziness, dry mouth, irritability, behavioral problems, and low blood pressure. Sudden cessation of medication may lead to hypertension.

Clonidine

Catapres-TTS patch

Up to 7 days

Fatigue, dizziness, dry mouth, irritability, behavioral problems, and low blood pressure. Sudden cessation of medication may lead to hypertension.

Clonidine

Kapvay

12 hours

Fatigue, dizziness, dry mouth, irritability, behavioral problems, and low blood pressure. Sudden cessation of medication may lead to hypertension.

Guanfacine

Intuniv

24 hours

Fatigue, dizziness, dry mouth, irritability, behavioral problems, and low blood pressure. Sudden cessation of medication may lead to hypertension.

Guanfacine

Tenex

6-8 hours

Fatigue, dizziness, dry mouth, irritability, behavioral problems, and low blood pressure. Sudden cessation of medication may lead to hypertension.

Veroxazine

Qelbree

12 Hours

Fatigue, dizziness, dry mouth, irritability, behavioral problems, and low blood pressure. Sudden cessation of medication may lead to hypertension.

Data source:WebMD


Currently, three transdermal drug delivery systems for the treatment of ADHD have been launched globally, with low API dosage requirements and long delivery times, which are consistent with the drug delivery characteristics of transdermal preparations. Compared to other oral preparations, the advantage is that transdermal administration may be suitable for children who do not like oral medication, and there are fewer gastrointestinal side effects. Once the patient experiences intolerance, medication can be stopped immediately to block the process of drug delivery. Most ADHD drugs belong to the category of precision stimulants, which carries the risk of addiction or abuse. The use of these stimulants is strictly regulated in various countries, especially in China. The transdermal patch delivery system, due to the characteristics of the preparation process, adds various preparation excipients, which makes it difficult to extract API components in reverse without authorization. Additionally, transdermal formulations can incorporate anti tear label sticking technology and deterrent agents to prevent ingestion by young children. In short, the prospects of the transdermal drug delivery system for children with ADHD are bright, and the road is bumpy and tortuous. Although the international community and drug regulatory agencies in various countries have launched many incentive policies to encourage children's drugs and dosage forms, the reality is that "praise is not praise". The ethical requirements of clinical research on children's drugs, as well as the various risks and difficulties of trial implementation, have led many "emotional" enterprises to support pediatric drug projects and more new technologies, Enterprises with new dosage forms are hesitant. The transdermal drug delivery system meets the requirements of releasing a total dose equal to or lower than conventional oral administration, with a peak blood drug concentration much lower than conventional oral therapeutic drugs, and a sustained efficacy time similar to oral sustained-release drugs. Its clinical application risk is much lower than that of oral sustained-release preparations. Currently, the main difficulty in research and development is to meet the requirements of approved Class 2.2 new drugs or FDA 505B2 application in terms of transdermal preparation production process and clinical efficacy.


END


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