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
-
Dose Optimization of Evening-Dosed DR/ER-MPH in Children with ADHD:
Efficacy and Safety From the 6-Week Open-Label Period of a Phase 3
Classroom Trial
Monday, May 20, 2019, Poster Session 06,
2:00-4:00PM
Presenter: Ann Catherine Childress, M.D.,
President, Center for Psychiatry and Behavioral Medicine, Inc., Las
Vegas, NV; investigator in JORNAY PM’s pivotal trial program
Product Theater
-
JORNAY PM: A Novel Delayed-Release and Extended-Release Treatment
for ADHD Patients 6 Years and Older
Monday, May 20, 2019,
Exhibit Halls A-C Exhibition Level Moscone Center Product Theater 1,
Booth #105, 1:00-2:00PM
Presenter: Andrew J. Cutler, M.D.
Executive Vice President & Chief Medical Officer, Meridien Research,
Bradenton, FL; Clinical Professor of Psychiatry, SUNY Upstate Medical
University, Syracuse, NY; investigator in JORNAY PM’s pivotal trial
program*
To schedule an interview with an investigator or Ironshore executive,
please contact Lora Grassilli at lgrassilli@klcpr.com.
| WARNING: ABUSE AND DEPENDENCE |
| See full prescribing information for complete boxed warning. |
|
| See additional safety information below. |
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 & 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
-
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.
ADVERSE REACTIONS
-
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 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 Grassilli
lgrassilli@klcpr.com