Market Overview

Ironshore Pharmaceuticals Announces FDA Approval of JORNAY PMTM (Methylphenidate) Extended-Release Capsules CII for the Treatment of ADHD

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  • JORNAY PM approved for the treatment of ADHD in patients 6 years
    and older
  • JORNAY PM is the only stimulant medication that is dosed in the
    evening and has demonstrated improvement in the severity of ADHD
    symptoms in the early morning and throughout the day
  • The commercial launch of JORNAY PM is planned for the first half of
    2019

Ironshore
Pharmaceuticals & Development, Inc.
("Ironshore") a wholly owned
subsidiary of Highland
Therapeutics Inc
. ("Highland") announced today that the U.S. Food
and Drug Administration (FDA) has approved the New Drug Application
(NDA) for JORNAY PM™ (methylphenidate) (formerly known as HLD200) for
the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in
patients 6 years and older. JORNAY PM is a novel formulation of
methylphenidate which is taken in the evening and has demonstrated
improvement in the severity of ADHD symptoms in the early morning and
throughout the day. JORNAY PM is the first drug utilizing Ironshore's
proprietary drug delivery platform, DELEXIS®.
Ironshore plans to initiate the commercial launch of JORNAY PM in the
first half of 2019.

WARNING: ABUSE AND DEPENDENCE

See full prescribing information for complete boxed warning.

  • 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

See additional safety information below

According to independent research reports commissioned by Ironshore,
control over the symptoms of ADHD during the early morning routine
remains a significant concern for parents of children with ADHD. As
previously reported in the Journal of Child and Adolescent
Psychopharmacology, a majority of surveyed parents of children with ADHD
report that the symptoms associated with ADHD in the early morning are
described as "moderate" or "severe" during this time period.1

Commenting on the approval, David Lickrish, President & CEO stated,
"Some manufacturers have adjusted the ratio of immediate-release and
extended-release features in different formulations of methylphenidate
to achieve an earlier onset. Our approach to drug development was to
start from the desired pharmacokinetic profile and then work to develop
a purpose-built technology capable of achieving that profile. I believe
that the unique DELEXIS® drug delivery platform is a
disruptive technology that has many applications and opportunities in
several therapeutic categories."

DELEXIS is a novel and proprietary drug delivery technology that
contains two functional film coatings that act synergistically to
achieve a unique pharmacokinetic profile. The first layer delays the
initial release of drug for up to 10 hours while the second layer helps
to control the rate of release of the active pharmaceutical ingredient
throughout the day.

Dr. Bev Incledon, Head of Research and Development at Ironshore stated,
"Developing a drug using a different delivery technology that will
provide an additional option for patients and the physicians who treat
them takes time. After 10 years of unrelenting determination, those
efforts have finally been rewarded with the approval of JORNAY PM. I
want to thank and congratulate the many people who helped to make this
possible including the formulation scientists, the Research &
Development Team, the Investigators and the patients who participated in
the clinical trials."

The effectiveness of JORNAY PM was established in two separate Pivotal
Phase III, multicenter, randomized, double-blind, placebo-controlled
studies conducted in a total of 278 pediatric patients aged 6 to 12
years with a diagnosis of ADHD per DSM-5 criteria. In addition to the
traditional scales that assess efficacy in ADHD clinical trials such as
the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale and
the ADHD Rating Scale (ADHD-RS-IV), Ironshore's pivotal trials assessed
JORNAY PM's efficacy in the early morning period using the morning
subscale of the Parent Rating of Evening and Morning Behavior-Revised
(PREMB-R AM) scale and the Before School Functioning Questionnaire
(BSFQ).

In Study 1, improvement in ADHD manifestations in a classroom setting
was demonstrated by the primary endpoint, an average of all post-dosed
SKAMP combined scores measured during a 12-hour period (8:00 a.m. to
8:00 p.m.), and improvement in ADHD manifestations in the early morning
was demonstrated by the secondary endpoint, PREMB-R AM.

In Study 2, improvement in ADHD manifestations throughout the day was
demonstrated by the primary endpoint, ADHD-RS-IV, and improvement in
ADHD manifestations before school was demonstrated by the secondary
endpoint, the BSFQ, which is intended to assess early morning before
school activities from the time the child awakens and some behaviors not
specific to early morning.

Commenting on the approval, Dr. Randy Sallee, Chief Medical Officer at
Ironshore stated, "Many parents of children with ADHD note that the
early morning routine is often one of the most chaotic times of the day.
The idea of dosing the medication the night before was our moon-shot
solution to meeting this need. The approval of JORNAY PM is a welcome
treatment option for healthcare providers, patients and their caregivers
that may affect the way physicians think about ADHD treatment going
forward."

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

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 INFORMATION2

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
  • Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use
    of an MAOI within the preceding 14 days

WARNINGS AND PRECAUTIONS

  • Serious Cardiovascular Reactions: Sudden death has been reported in
    association with CNS stimulants at recommended doses in pediatric
    patients with structural cardiac abnormalities or other serious heart
    problems. In adults, sudden death, stroke, and myocardial infarction
    have been reported. Avoid use in patients with known structural
    cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, or
    coronary artery disease.
  • Blood Pressure and Heart Rate Increases: Monitor blood pressure and
    pulse. Consider the benefits and risks in patients for whom an
    increase in blood pressure or heart rate would be problematic.
  • Psychiatric Adverse Reactions: Use of CNS stimulants may cause
    psychotic or manic symptoms in patients with no prior history, or
    exacerbation of symptoms in patients with pre-existing psychiatric
    illness. Evaluate for bipolar disorder prior to JORNAY PM use.
  • Priapism: Cases of painful and prolonged penile erections and priapism
    have been reported with methylphenidate products. 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: 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.

Please see additional safety information in the Full Prescribing
Information for JORNAY PM at http://ironshorepharma.com/labeling.pdf.

REFERENCES

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;25(7):558–565.

2. JORNAY PM [package
insert
]. Ironshore Pharmaceuticals & Development, Inc.; 2018.

About Ironshore Pharmaceuticals & Development, Inc.

Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary
of Highland Therapeutics Inc., is a pharmaceutical company that is
leveraging its proprietary drug delivery platform, DELEXIS®, to optimize
the delivery of previously approved drug products.

Highland Therapeutics Inc. is a client of MaRS Discovery District's
Health Venture Services group, which provides advisory services,
connections to talent, customer and capital networks, and market
intelligence to high-impact, Ontario, Canada-based life sciences
ventures, helping them commercialize their ideas and build globally
competitive companies. For more information, visit
Highlandtherapeutics.com

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.

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