Breaking News
February 17, 2019 - Support from trusted adults can reduce risk of dying in suicidal teens, finds study
February 17, 2019 - Heart attack awareness improved since 2008
February 17, 2019 - Exercise gives a better brain boost to older men than women
February 17, 2019 - New research disproves previous assumptions of how looks influence personality
February 17, 2019 - Cannabis use as a teenager linked to depression later in life
February 17, 2019 - Sinks by Toilets in ICU Patient Rooms Harbor Harmful Bacteria
February 17, 2019 - Cancer cells’ plasticity makes them harder to stop
February 17, 2019 - Young cannabis users have increased risk of depression and suicidal behavior
February 17, 2019 - Tasmanian Devils Likely to Survive Cancer Scourge
February 17, 2019 - Neoadjuvant PD-1 blockade seems effective in glioblastoma
February 17, 2019 - Personal, social factors play role in enabling sustainable return to work after ill health
February 17, 2019 - Mouse studies show ‘inhibition’ theory of autism wrong
February 17, 2019 - Study shows how neuroactive steroids inhibit activity of pro-inflammatory proteins
February 17, 2019 - Use of liver grafts from older donors decreased despite better outcomes in recipients
February 17, 2019 - MUSC researchers discover new mechanism for a class of anti-cancer drugs
February 17, 2019 - HPV misconceptions are causing women to miss smear tests
February 17, 2019 - Sanofi and Regeneron Offer Praluent (alirocumab) at a New Reduced U.S. List Price
February 17, 2019 - Researchers say auditory testing can identify children for autism screening
February 17, 2019 - New method analyzes how single biological cells react to stressful situations
February 17, 2019 - WVU gynecologic oncologist investigates novel treatment for cervical and vaginal cancers
February 17, 2019 - ADHD diagnoses poorly documented
February 17, 2019 - Majority of gender minority youth do not identify with traditional sexual identity labels
February 17, 2019 - AbbVie, Teneobio enter into strategic transaction to develop potential treatment for multiple myeloma
February 17, 2019 - Lower Birth Weight May Up Risk for Psychiatric Disorders
February 17, 2019 - Scientists identify reversible molecular defect underlying rheumatoid arthritis
February 17, 2019 - Moffitt researchers shed light on how CAR T cells function mechanistically
February 16, 2019 - Female Anatomy May Play Big Role in Sperm’s Success
February 16, 2019 - BMI may mediate inverse link between fiber intake, knee OA
February 16, 2019 - Movement impairments in autism can be reversed through behavioral training
February 16, 2019 - Studies address racial disparities in postpartum period and cardiovascular health
February 16, 2019 - Scientists implicate hidden genes in the severity of autism symptoms
February 16, 2019 - Decreased deep sleep linked to early signs of Alzheimer’s disease
February 16, 2019 - Neuroscientists show how the brain responds to texture
February 16, 2019 - Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
February 16, 2019 - What Can I Do About Sweating? (for Teens)
February 16, 2019 - Companies navigate dementia conversations with older workers
February 16, 2019 - Newly developed stem cell technologies show promise for treating PD patients
February 16, 2019 - Collaborative material research could advance self-assembling nanomaterials
February 16, 2019 - Researchers take major step in creating technology that mimics the human brain
February 16, 2019 - Erasing memories associated with cocaine use reduces drug seeking behavior
February 16, 2019 - Artificial intelligence can accurately predict prognosis of ovarian cancer patients
February 16, 2019 - Racial disparities in cancer deaths on the decline for America
February 16, 2019 - FDA authorizes new interoperable insulin pump for children, adults with diabetes
February 16, 2019 - Coexisting Medical Conditions, Smoking Explain PTSD-CVD Link
February 16, 2019 - Skin Cancer Screening: MedlinePlus Lab Test Information
February 16, 2019 - ‘Happiness’ exercises can boost mood in those recovering from substance use disorder
February 16, 2019 - Cell manipulation could soon halt or reverse aging
February 16, 2019 - Pumped Breast Milk Falls Short of Breastfed Version
February 16, 2019 - Men’s porn habits could fuel partners’ eating disorders, study suggests
February 16, 2019 - Rapid progression of age-related diseases may result from formation of vicious cycles
February 16, 2019 - Immune checkpoint molecule protects against future development of cancer
February 16, 2019 - New method produces hydrogels that have properties similar to cells’ environment
February 16, 2019 - $4.1 million funding for heart research on Valentine’s Day
February 16, 2019 - General anesthesia in early infancy unlikely to have lasting effects on developing brains
February 16, 2019 - New breakthroughs for muscular dystrophy research
February 16, 2019 - First Opinion: Embryo editing for higher IQ is a fantasy. Embryo profiling for it is almost here
February 16, 2019 - Vapers develop cancer-related gene deregulation as cigarette smokers
February 16, 2019 - Bringing Antimicrobial Susceptibility Testing (AST) to the Community
February 16, 2019 - Decolonization protocol after hospital discharge can prevent dangerous infections
February 16, 2019 - Children with ASD more likely to face maltreatment, study finds
February 16, 2019 - Study finds genetic vulnerability to use of menthol cigarettes
February 16, 2019 - Promising drug developed to rejuvenate muscle cells
February 16, 2019 - H-RT should be the standard of care for men with low risk prostate cancer, study shows
February 16, 2019 - New technique using patients’ own modified cells could help treat Crohn’s disease
February 16, 2019 - Therapeutic endoscopy has an expanding role in the treatment of IBD
February 16, 2019 - Blood clot discovery could lead to development of better treatments for blood diseases
February 16, 2019 - Intervention can increase exclusive breastfeeding rates
February 16, 2019 - New project explores how gaming technologies can help cancer patients communicate better
February 16, 2019 - Catalyst Biosciences Presents Updated Data from Its Phase 2/3 Trial of Subcutaneous Marzeptacog Alfa (Activated) in Individuals with Hemophilia A or B with Inhibitors at the 12th Annual EAHAD Congress
February 16, 2019 - Rerouting nerves during amputation reduces phantom limb pain before it starts
February 16, 2019 - A Hormone Produced When We Exercise Might Help Fight Alzheimer’s
February 16, 2019 - Millions of British people breathe toxic air travelling to GPs
February 16, 2019 - Conformance of genetic characteristics found to be crucial for longer preservation of kidney graft
February 16, 2019 - Researchers use optogenetic tool to control, visualize receptor signals in neural cells
February 16, 2019 - New reversible antiplatelet therapy could reduce risk of blood clots, prevent cancer metastasis
February 16, 2019 - Testosterone is not the only hormone needed for penis development
February 16, 2019 - FDA Advisory Committee Recommends Approval of Spravato (esketamine) Nasal Spray for Adults with Treatment-Resistant Depression
February 15, 2019 - Heart surgery technology developed at Baptist Health debuts after years of secrecy
February 15, 2019 - Prescription Opioids Double Risk of Triggering Fatal Car Crash
February 15, 2019 - New study helps doctors better understand high blood pressure in pregnant women
FDA Approves Jornay PM (methylphenidate) Extended-Release Capsules for Attention Deficit Hyperactivity Disorder (ADHD)

FDA Approves Jornay PM (methylphenidate) Extended-Release Capsules for Attention Deficit Hyperactivity Disorder (ADHD)

image_pdfDownload PDFimage_print

FDA Approves Jornay PM (methylphenidate) Extended-Release Capsules for Attention Deficit Hyperactivity Disorder (ADHD)

GEORGE TOWN, Cayman Islands–(BUSINESS WIRE)August 09, 2018 –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.

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.

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.

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.

Source: Ironshore Pharmaceuticals & Development, Inc.

Posted: August 2018

Jornay PM (methylphenidate hydrochloride) FDA Approval History

Tagged with:

About author

Related Articles