Ironshore Pharmaceuticals to Showcase JORNAY PM™ (Methylphenidate HCl) CII at the 2019 American Psychiatric Association Meeting
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Company to Present Pivotal Trial Data and Sponsor Product Theater
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Ironshore Pharmaceuticals (“Ironshore”), a leader in the commercialization of novel treatments for Attention Deficit Hyperactivity Disorder (“ADHD”), today announced that it will present data from a pivotal trial of JORNAY PM™ (methylphenidate) extended-release capsules CII at the 2019 American Psychiatric Association (“APA”) meeting in San Francisco, CA, May 18-22, 2019. JORNAY PM (formerly HLD200) is a CNS stimulant approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of ADHD in patients 6 years and older and will be commercially available the first week in June. Attendees are encouraged to visit Ironshore representatives at Booth #319 to learn more about JORNAY PM.
“JORNAY PM is the first and only ADHD stimulant dosed in the evening. Ironshore is proud to share results from the open-label portion of one of the pivotal trials with the psychiatric community,” said Dr. Randy Sallee, Ironshore’s Chief Medical Officer. “For patients with ADHD, the early morning can be particularly challenging. JORNAY PM’s unique delayed-release and extended-release technology is what enables JORNAY PM to be dosed in the evening. When taken the night before, JORNAY PM is designed to provide control of ADHD symptoms in the early morning and throughout the day. JORNAY PM’s unique value proposition – supported by nine clinical studies, including two pivotal trials – represents a welcome addition to the armamentarium of treatment options available for patients with ADHD.”
Ironshore-sponsored activities at this year’s APA meeting include:
Poster Presentation
Product Theater
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 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.
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 its proprietary drug-delivery technology, DELEXIS®. Ironshore Pharmaceuticals and Development, Inc. is a wholly owned subsidiary of Highland Therapeutics Inc. based in Toronto, Canada.
This is an informational event provided by Ironshore Pharmaceuticals. Participants cannot claim CME credit for attending this informational event and participation may be subject to reporting under the Sunshine Act. The Industry Product Theater’s content and the views expressed therein are those of Ironshore Pharmaceuticals and not of APA.
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
Lora Grassillilgrassilli@klcpr.com
Lora Grassillilgrassilli@klcpr.com
