Breaking News
September 18, 2018 - Protect your heart and health during ‘dog days’ of summer
September 18, 2018 - Faculty receive awards for promise in biomedical research, clinical care | News Center
September 18, 2018 - Digital games for CVD-related self-management improve exercise capacity and energy expenditure
September 18, 2018 - Adding PET scans to CT imaging can change treatment for women with cervical cancer
September 18, 2018 - Zika virus vaccine shows promise for treatment of fatal glioblastoma
September 18, 2018 - Theravance Biopharma and Mylan to Report New Data from Phase 3 Studies of Yupelri (revefenacin) in Oral Presentation at European Respiratory Society International Congress 2018
September 18, 2018 - INSiGHT identifies unique retinal regulatory genes
September 18, 2018 - Diversity, science leadership grants awarded to student-faculty pairs | News Center
September 18, 2018 - Many parents blame electronics for sleep problems among teens
September 18, 2018 - Researchers study neuronal activity in brain that prevents individuals from doing physical activity
September 18, 2018 - Purifying Proteins from Mammalian Cell Culture
September 18, 2018 - Researchers map 3D structure of toxic proteins used by Pseudomonas aeruginosa to trigger infection
September 18, 2018 - Outcome of ACL reconstruction related to the way you move post-surgery
September 18, 2018 - Study aims to investigate risk factors for PPCs in surgical patients with gastric cancer
September 18, 2018 - Ardelyx Submits New Drug Application for Tenapanor for IBS-C
September 18, 2018 - Sociodemographic disparities in eyeglass use among elderly
September 18, 2018 - New Drug Shows Promise for Progressive Form of MS
September 18, 2018 - Babies exposed to higher levels of organochlorine compounds in womb may have worse lung function
September 18, 2018 - Women exposed to trauma in their lives gave birth to underweight male infants
September 18, 2018 - Probiotic supplementation may reduce use of antibiotics, scientific analysis shows
September 18, 2018 - Resveratrol decreases pain severity and levels of inflammatory biomarkers in osteoarthritis patients
September 18, 2018 - Research shows pollution is reaching the placenta
September 18, 2018 - KAIST researchers develop heart-targeting drug delivery technology using tannin acid
September 18, 2018 - Muscle relaxants used during general anesthesia can increase risk of pulmonary complications
September 18, 2018 - Silicone breast implants may increase risk of rare adverse outcomes in women
September 18, 2018 - Pediatricians Have a Role in Encouraging Play Among Children
September 18, 2018 - California’s Medicaid program hits ‘print’ when the feds need info
September 18, 2018 - Genes, environment and schizophrenia—new study finds the placenta is the missing link
September 18, 2018 - Boehringer Ingelheim announces study results of COPD patients treated with Spiolto Respimat
September 18, 2018 - PAREXEL launches Patient Innovation Center to improve drug development process
September 18, 2018 - Children’s National and NIAID launch pediatric clinical research partnership
September 18, 2018 - Researchers may be overlooking complexities in social relations of primates
September 18, 2018 - Key signaling molecule that helps stem cells make healthy bone declines as we age
September 18, 2018 - More women veterans with chronic pain use CIH therapies than men
September 18, 2018 - As Earth Warms, Heat-Related Deaths Will Multiply
September 18, 2018 - Labetalol use up for patients with preeclampsia and asthma
September 18, 2018 - MoreGrasp project shows significant results in field of thought-controlled grasp neuroprosthetics
September 18, 2018 - Drumming can benefit school children with autism
September 18, 2018 - Busyness can help people to make virtuous choices, research shows
September 18, 2018 - Two-minute bursts of in-class exercise breaks do not disrupt learning and teaching
September 18, 2018 - New online tools aid surgeons and specialists who care for older people
September 18, 2018 - Researchers use CRISPR to identify gene that helps cells resist flavivirus infection
September 18, 2018 - Brain’s support cells may play a central role in repetitive behaviors related to OCD
September 18, 2018 - Scientists discover novel mechanism by which synthesized proteins reach target compartment in cell
September 18, 2018 - Easy and rapid test for viral infections can cut antibiotic use, hospitalizations
September 18, 2018 - Gunshot victims more likely to require blood transfusions and die than other trauma patients
September 18, 2018 - Cyclacel Pharmaceuticals Announces Initiation of Phase 1b/2 Clinical Trial of Sapacitabine With Olaparib in BRCA Mutant Breast Cancer
September 18, 2018 - Older adults fitted with cochlear implants exhibit poor brain function
September 18, 2018 - Inexpensive testing spurs cancer patients’ relatives to assess own disease risk | News Center
September 18, 2018 - Aging may have originated at the very beginning of life, says study
September 18, 2018 - New research on sperm quality updates advice for couples trying to conceive
September 18, 2018 - Paracetamol use in infancy may increase risk of developing asthma by the age of 18
September 18, 2018 - Promising gene therapy for ‘day blind’ sheep now safe for clinical trials in human patients
September 18, 2018 - New research shows evidence of soot from polluted air in placentas
September 17, 2018 - Expanding primary care buprenorphine treatment could curb opioid overdose crisis
September 17, 2018 - A look inside the child detention centers near the U.S. border
September 17, 2018 - New issue considers role of coronary angiography after cardiac arrest
September 17, 2018 - Scientists explore whether seafood could be the source of next anti-cancer drug
September 17, 2018 - Epidural stimulation aids in recovery of individuals with spinal cord injury
September 17, 2018 - ATS publishes new guideline on role of weight management in sleep apnea treatment
September 17, 2018 - Study reveals long-term safety, efficacy of Ofev in patients with idiopathic pulmonary fibrosis
September 17, 2018 - Risks Posed by Spreading Oil and Gas Wastewater on Roads
September 17, 2018 - How to choose a nursing home: MedlinePlus Medical Encyclopedia
September 17, 2018 - Death from touching fentanyl? A myth, says Trump administration training video
September 17, 2018 - Physician or physician-scientist — a new curriculum at the School of Medicine trains both
September 17, 2018 - Why Genetic Mutations Cause Disease in Some People but Not Others
September 17, 2018 - EU-funded project makes recommendations to protect rights of intersex people
September 17, 2018 - Discovery of unusual biosynthetic pathways could aid in the search for new natural products
September 17, 2018 - FDA approves Teva’s AJOVY injection for preventive treatment of migraine in adults
September 17, 2018 - People battling substance use disorders may benefit from meth-relapse prevention compound
September 17, 2018 - Inhaled steroid use linked to greater risk of NTM lung infections
September 17, 2018 - KKH develops new test to enable faster diagnosis of critically ill children with rare diseases
September 17, 2018 - How to Reassure Kids When Florence Strikes
September 17, 2018 - Scientists develop new technique to heal large ulcers by reprogramming wound cells into skin cells
September 17, 2018 - How researchers are working to render disease obsolete
September 17, 2018 - Study confirms link between use of muscle relaxants and respiratory complications
September 17, 2018 - Machine learning program could distinguish between two lung cancer types
September 17, 2018 - Ensysce receives award from NIDA to undertake development of opioid overdose protection platform
September 17, 2018 - Women with undiagnosed STIs may be at greater risk of negative premenstrual symptoms
September 17, 2018 - New discovery could improve diagnosis and treatment of lupus in black Africans
Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

image_pdfDownload PDFimage_print

solriamfetol

Treatment for Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome

Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

DUBLIN, March 2, 2018 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with standard review the company’s New Drug Application (NDA) seeking marketing approval for solriamfetol, an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is December 20, 2018.

“We believe this medicine will provide a meaningful option for patients living with excessive sleepiness due to narcolepsy or OSA, and we look forward to working with the FDA during the review process for solriamfetol,” said Karen Smith, M.D., Ph.D., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals. “Jazz continues to invest in ongoing research, education and advocacy on behalf of the sleep community, including studying solriamfetol for the treatment of excessive sleepiness in other areas of unmet need, such as Parkinson’s disease.”

The solriamfetol Phase 3 clinical program includes one study evaluating excessive sleepiness in adult patients with narcolepsy (TONES 2), two studies evaluating excessive sleepiness in adult patients with OSA (TONES 3 and TONES 4), and an open-label, long-term safety and maintenance of efficacy study (TONES 5) in the treatment of excessive sleepiness in patients with narcolepsy or OSA.

About OSA and Excessive Sleepiness

OSA is a prevalent disease (as high as 14% in men and 5% in women) with excessive sleepiness being a major presenting complaint in many cases.1,2 Excessive sleepiness in OSA is associated with impairments in cognitive function, safety, productivity, interpersonal relationships, and overall quality of life. Positive Airway Pressure (PAP) therapy, with its most common form being Continuous Positive Airway Pressure (CPAP), has been shown to be an effective therapy for sleep-related airway obstruction, with frequent improvement in excessive sleepiness in many patients; however, not all patients tolerate CPAP therapy and among those who tolerate CPAP, usage is highly variable. It is estimated that excessive sleepiness persists in 13%–65% of people utilizing CPAP for OSA.3,4,5

About Narcolepsy

Narcolepsy is a debilitating neurological disorder characterized by excessive sleepiness, and the inability to regulate sleep-wake cycles normally.6 It affects an estimated one in 2,000 people in the United States, with symptoms typically appearing in early adulthood. It is estimated that more than 50% of patients with narcolepsy have not been diagnosed.7 Studies have shown it may take 10 years or more for people with narcolepsy to receive a correct diagnosis.8 Excessive sleepiness is the primary symptom of narcolepsy and is present in all people with the disorder.2 Excessive sleepiness is characterized by the inability to stay awake and alert during the day resulting in unplanned lapses into sleep or drowsiness.2,7,9

About Solriamfetol (JZP-110)

Solriamfetol (JZP-110) is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for treatment of excessive sleepiness in adult patients with narcolepsy, OSA, and Parkinson’s disease. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals, the discoverer of the compound (also known as SKL-N05), maintains rights in 12 Asian markets, including Korea, China and Japan. Solriamfetol has orphan drug designation in the United States for narcolepsy.

About Jazz Pharmaceuticals plc

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Defitelio® (defibrotide sodium) and Vyxeos® (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S. For country-specific product information, please visit www.jazzpharmaceuticals.com/products. For more information, please visit www.jazzpharmaceuticals.com and follow us on Twitter at @JazzPharma.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to solriamfetol (JZP-110) as a potential treatment for excessive sleepiness in adult patients with narcolepsy or OSA, including the company’s belief that solriamfetol will provide a meaningful option for patients with excessive sleepiness due to narcolepsy or OSA, and other statements that are not historical facts. These forward-looking statements are based on the company’s current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: pharmaceutical product development; the regulatory approval process, including the risk that the company is unable to obtain FDA approval for solriamfetol in a timely manner or at all; and the manufacture and effective commercialization of solriamfetol, and other risks and uncertainties affecting the company and its development programs, including those described from time to time under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals plc’s Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company’s Annual Report on Form 10-K for the year ended December 31, 2017 and future filings and reports by the company. Other risks and uncertainties of which the company is not currently aware may also affect the company’s forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the company on its website or otherwise. The company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

References:

1. Peppard AE, et al. Increased Prevalence of Sleep-Disordered Breathing in Adults. Am J Epidemiol. 2013;177(9):1006-1014.
2. American Academy of Sleep Medicine. The International Classification of Sleep Disorders. Third Edition (ICSD-3). 2014.
3. Weaver TE, Maislin G, Dinges DF, et al. Relationship Between Hours of CPAP Use and Achieving Normal Levels of Sleepiness and Daily Functioning. Sleep. 2007;30(6):711–719.
4. Gasa M, Tamisier R, Launois SH, et al. Residual sleepiness in sleep apnea patients treated by continuous positive airway pressure. J Sleep Res. 2013;22(4):389–397.
5. Koutsourelakis I, Perraki E, Economou NT, et al. Predictors of residual sleepiness in adequately treated obstructive sleep apnoea patients. Eur Respir J. 2009;34(3):687–693.
6. Thorpy M, Krieger A. Delayed diagnosis of narcolepsy: characterization and impact. Sleep Medicine. 2014;15(5):502–507.
7. Ahmed I, Thorpy, M. Clinical Features, Diagnosis and Treatment of Narcolepsy. Clin Chest Med. 2010;31(2):371-381.
8. Morrish E, King M, et al. Factors associated with a delay in the diagnosis of narcolepsy. Sleep Medicine. 2004;5(1):37-41.
9. Ahmed I, Thorpy, M. Sleepiness: Causes, Consequences and Treatment, ed. Cambridge University Press. 2011:36-49.

SOURCE Jazz Pharmaceuticals plc

Posted: March 2018

Related Articles

solriamfetol FDA Approval History

About author

Related Articles