RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Children all over the country have been heading back to school over the past few weeks, which means a return to many hectic mornings and busy after-school activity periods. For families with members who are affected by Attention Deficit Hyperactivity Disorder (ADHD), mornings can be especially difficult. In a survey of 200 parents of children diagnosed with ADHD, over 90 percent felt that ADHD symptoms negatively impacted their early morning routine1. Ironshore Pharmaceuticals Inc. (Ironshore) recently introduced the Rate My Mornings Quiz, an interactive tool designed to help families identify how ADHD affects their mornings. To take the quiz, learn useful tips, and access a Doctor Discussion Guide to help start the conversation about mornings and ADHD with your doctor, visit www.jornaypm.com
WARNING: ABUSE AND DEPENDENCE
See full prescribing information for complete boxed warning.
In June 2019, Ironshore launched JORNAY PM™ (methylphenidate HCl) extended-release capsules CII, a medication clinically proven to control ADHD symptoms from the time a patient wakes up and last throughout the day. JORNAY PM is a CNS stimulant indicated for the treatment of ADHD in patients six years and older that is taken in the evening.
Contraindications to JORNAY PM include known hypersensitivity to methylphenidate or other components of JORNAY PM. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products. Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days because of the risk of hypertensive crisis. Please see additional important safety information for JORNAY PM below.
JORNAY PM is the first product to leverage the novel DELEXIS® delayed-release and extended-release drug delivery technology. After the once-daily dose of JORNAY PM is taken in the evening, the delayed-release layer keeps it from working overnight for about 12 hours. JORNAY PM then starts working in the early morning and the extended-release layer controls the rate of medication release to control ADHD symptoms throughout the day and into the evening.
“ADHD symptoms in kids, teens and adults start as soon as they wake up which can make it a struggle to follow directions and complete everyday morning tasks such as brushing teeth and sitting down for breakfast,” said Dr. Ann Childress, M.D., President, Center for Psychiatry and Behavioral Medicine, Inc. in Las Vegas and Clinical Trial Investigator. “Several families I work with have developed a number of creative, but often disruptive, strategies in an attempt to improve the early morning routine. It’s important to talk to your doctor about how ADHD affects your family and to work together to identify what type of medication or behavioral treatments are going to be the best for you and your child.”
An estimated 11 percent of school-age children in the United States are affected by ADHD2 including 11-year-old Sean. Mornings were a struggle for Sean and his family. Sean’s mother Jenn recalled, “It was hard for Sean in the morning because his medicine was not yet in his system. Sometimes the mornings could just be a screaming match, and sometimes there were tears for both Sean and myself.”
ADHD symptoms are there from the moment Sean wakes up, so his mother would wake him up early to give him his medication and then let him go back to sleep for a little while, until the medicine started to work. Sean and his family talked to his doctor, Dr. Ann Childress, about his difficulties in the morning, and Dr. Childress invited Sean and his family to be part of a clinical trial for JORNAY PM.
While individual results will vary for each patient, Sean’s mother reported that during the trial, Sean’s ADHD symptoms were under control in the early morning and throughout the day. When the trial ended, Sean’s mother constantly asked when JORNAY PM would be available because she was eager to have Sean switched to it. Following the availability of JORNAY PM in the United States, Dr. Childress prescribed the product for Sean. Since he has begun taking JORNAY PM earlier in the summer, Sean’s mom noted that Sean’s ADHD symptoms were controlled from the time Sean awoke through the rest of the day. “Our mornings heading back to school this year have been very different from previous years. We are so glad that we found JORNAY PM”.
ADHD is among the most common childhood psychiatric conditions with behavioral symptoms fluctuating throughout the day. It is usually first diagnosed in childhood and often lasts into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviors, or be overly active. Many home-based difficulties for children and adolescents with ADHD occur during the early morning routine (i.e. before the school day begins).
About JORNAY PM
Developed by Ironshore Pharmaceuticals & Development, Inc., JORNAY PM is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. JORNAY PM may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD. It is not known if JORNAY PM is safe and effective in children under 6 years of age.
JORNAY PM is dosed once daily in the evening and should be initiated at 8:00 p.m. Timing of administration of JORNAY PM may be adjusted between 6:30 p.m. and 9:30 p.m. to optimize the tolerability and the efficacy the next morning and throughout the day. Please see additional dosing information in the full prescribing information for JORNAY PM at http://ironshorepharma.com/labeling.pdf.
IMPORTANT SAFETY INFORMATION
WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including JORNAY PM, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
- Known hypersensitivity to methylphenidate or other components of JORNAY PM. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products.
- Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days because of the risk of hypertensive crisis.
WARNINGS AND PRECAUTIONS
- Serious Cardiovascular Reactions: Sudden death, stroke, and myocardial infarction have been reported in adults treated with CNS stimulants at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, coronary artery disease, and other serious cardiac problems.
- Blood Pressure and Heart Rate Increases: CNS stimulants may cause an increase in blood pressure and heart rate. Monitor all patients for hypertension and tachycardia.
- Psychiatric Adverse Reactions: CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychiatric disorder and may induce a manic or mixed episode in patients with bipolar disorder. In patients with no prior history of psychotic illness or mania, CNS stimulants, at recommended doses, may cause psychotic or manic symptoms.
- Priapism: Prolonged and painful erections, sometimes requiring intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism has also appeared during a period of drug withdrawal. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.
- Peripheral Vasculopathy, including Raynaud’s Phenomenon:CNS stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
- Long-Term Suppression of Growth: CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor height and weight at appropriate intervals in pediatric patients.
- Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions for pediatric patients and adults are: appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased.
- Additional adverse reactions (≥5% and twice the rate of placebo) in pediatric patients 6 to 12 years treated with JORNAY PM: headache, psychomotor hyperactivity, and mood swings.
PREGNANCY AND LACTATION
- CNS stimulant medications, such as JORNAY PM, can cause vasoconstriction and thereby decrease placental perfusion.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for JORNAY PM and any potential adverse effects on the breastfed infant from JORNAY PM or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
Please visit http://ironshorepharma.com/labeling.pdf for additional important safety information and the Full Prescribing Information, including Boxed Warning, for JORNAY PM.
About Ironshore Pharmaceuticals Inc.
Ironshore Pharmaceuticals Inc. commercializes innovative, patient-centric treatment options to improve the lives of patients and caregivers. Based in North Carolina, Ironshore Pharmaceuticals Inc. is responsible for the sales, marketing and distribution of pharmaceutical products within the US. Ironshore Pharmaceuticals Inc. is a wholly owned subsidiary of Highland Therapeutics Inc. based in Toronto, Canada.
About Ironshore Pharmaceuticals & Development, Inc.
Ironshore Pharmaceuticals & Development, Inc., based in Grand Cayman, develops novel therapeutics by leveraging its proprietary drug-delivery technology, DELEXIS®. Ironshore Pharmaceuticals & Development, Inc. is a wholly owned subsidiary of Highland Therapeutics Inc. based in Toronto, Canada.
This press release contains forward-looking information, which reflects Ironshore’s current expectations regarding future events. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond Ironshore’s control that could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking information. These forward-looking statements are made as of the date of this press release and, except as expressly required by applicable law, Ironshore assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
1 Sallee FR. Early Morning Functioning in Stimulant-Treated Children and Adolescents with Attention-Deficit/ Hyperactivity Disorder, and its Impact on Caregivers. J Child Adolescent Psychopharmacology. 2015
2 Visser SN, Danielson ML, Bitsko RH, Holbrook JR, Kogan MD, Ghandour RM, … Blumberg SJ. Trends in the parent-report of health care provider-diagnosed and medicated attention-deficit/hyperactivity disorder: United States, 2003–2011. Journal of the American Academy of Child and Adolescent Psychiatry. 2014;53(1):34–46. e32.