Ironshore Pharmaceuticals to Present Data at the 66th Annual AACAP Meeting
Tags:
Pediatric
ADHD
Data to Highlight Improvement in ADHD Functioning During the Early Morning and Evening Bedtime Routines in Children Treated with JORNAY PM™
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Ironshore Pharmaceuticals Inc. (“Ironshore”), a wholly owned subsidiary of Highland Therapeutics Inc. and a leader in the commercialization of novel treatments for Attention-Deficit/Hyperactivity Disorder (“ADHD”), today announced that it will present two posters at the 66th Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP) in Chicago, October 14-19, 2019, including data from a pivotal trial of JORNAY PM™ (methylphenidate HCl) extended-release capsules CII for the treatment of ADHD in patients 6 years and older. Attendees are encouraged to visit Ironshore representatives at Booth #133 to learn more about JORNAY PM.
JORNAY PM is the only stimulant medication that is dosed in the evening, demonstrating improvement in the severity of ADHD symptoms in the early morning and throughout the day. JORNAY PM became commercially available in the United States in June 2019.
WARNING: ABUSE AND DEPENDENCE
See full prescribing information for complete boxed warning.
See additional important safety information below.
“We look forward to engaging with healthcare professionals and presenting new data at this year’s American Academy of Child and Adolescent Psychiatry meeting, including findings from one of our pivotal trials which demonstrated that JORNAY PM improved ADHD symptoms in children during both early morning and late-afternoon/evening activities,” said Dr. Randy Sallee, Ironshore’s Chief Medical Officer. “Families who have children with ADHD understand that mornings can be a challenging time of the day. With the recent introduction of JORNAY PM, healthcare professionals can offer a stimulant medication that is dosed in the evening and begins working when the patient wakes up, lasts throughout the day, and into the evening.”
Ironshore-sponsored data at this year’s AACAP meeting include:
Clinical Responses and Symptomatic Remissions Achieved with Delayed-Release and Extended-Release Methylphenidate in Children with Attention-Deficit/Hyperactivity Disorder
Poster #6.48; Saturday, October 19, 2019; 10:00am – 12:30pm CDT, Hyatt Regency Chicago, Exhibit Hall Level, East Tower
Dr. Andrew J. Cutler to present
Achievement and Maintenance of Normalized Levels of Early Morning and Late Afternoon/Evening Functional Impairment with Delayed-Release and Extended-Release Methylphenidate (DR/ER-MPH) in Children With ADHD: Post Hoc Analyses of Before-School Functioning Questionnaire (BSFQ) and Parent Rating of Evening and Morning Behavior Scale-Revised (PREMB-R) by Norm-Referenced Cut-Offs
Poster #6.51; Saturday, October 19, 2019; 10:00am – 12:30pm CDT, Hyatt Regency Chicago, Exhibit Hall Level, East Tower
Stephen V. Faraone, PhD to present
To schedule an interview with an investigator or Ironshore executive, please contact Lora Grassilli at lgrassilli@klcpr.com.
About ADHD
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 and 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 six years of age and older. JORNAY PM may help increase attention and decrease impulsiveness and hyperactivity in people six years of age and older with ADHD. It is not known if JORNAY PM is safe and effective in children under six 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.
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
PREGNANCY AND LACTATION
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 and Development, Inc.
Ironshore Pharmaceuticals and Development, Inc., based in Grand Cayman, develops novel therapeutics by leveraging the DELEXIS® drug-delivery technology. Ironshore Pharmaceuticals and Development, Inc. is a wholly owned subsidiary of Highland Therapeutics Inc. based in Toronto, Canada.
Forward-Looking Statements
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.
Contacts
Nelson F. Isabel, Chief Financial Officer Ironshore Pharmaceuticals & Development, Inc. (345) 749-8170 Media Contact Lora Grassilli Kovak-Likly Communications (203) 762-8833 lgrassilli@klcpr.com
Nelson F. Isabel, Chief Financial Officer Ironshore Pharmaceuticals & Development, Inc. (345) 749-8170 Media Contact Lora Grassilli Kovak-Likly Communications (203) 762-8833 lgrassilli@klcpr.com
