The FDA determined that an NDA submission made by Jazz during the course of discussions regarding draft labeling for solriamfetol constitutes a major amendment to the NDA, resulting in a three-month extension of the PDUFA goal date to provide time for a full review of the submission.
"We appreciate the opportunity to work with the FDA to complete the review process as soon as possible," said Jed Black, M.D., senior vice president, Sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine. "We are committed to addressing unmet needs in sleep medicine and look forward to offering solriamfetol as a meaningful treatment option for patients living with excessive daytime sleepiness associated with narcolepsy or OSA."
About Solriamfetol
Solriamfetol 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 therapeutic 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®, Defitelio® (defibrotide) and Vyxeos® 44 mg/100 mg powder for concentrate for solution for infusion in countries outside the U.S. For country-specific product information, please visit http://www.jazzpharmaceuticals.com/products. For
Research points to a very long list of benefits from exercise, from improving your overall health to easing stress and enhancing mental well-being. But a landmark study in the journal Circulation highlights a negative, yet specific, concern.
ReplyDeleteWhile health factors like obesity and diabetes are known heart attack triggers, data from 12,500 people in 52 countries pointed to two other risk factors to be aware of: exercising at a very high level of physical exertion; and anger or emotional distress.
Either can double the risk of a heart attack. And when combined, they're even more dangerous, tripling the risk. So, while you might take a walk around the block to cool off when you're angry, it's not the time to bench press 300 pounds at the gym.
Does this mean you should never challenge yourself with strenuous workouts? Not necessarily. For an external trigger such as exercise to bring on a heart attack, there probably needs to be an existing problem, like cholesterol build-up in your arteries, researchers explained.
Regular activity is associated with heart benefits, according to the American College of Cardiology. The person who faces a risk from exercise is more likely to be someone out-of-shape who jumps into vigorous exertion suddenly. That's a reminder that the best approach is to start slow, and increase duration and intensity at a slow yet steady pace.
Also, to rein in strong emotions, make stress reduction and anger management part of your heart disease prevention plan. Consider making time for daily meditation, a few minutes of deep breathing twice a day and/or engaging in pursuits that bring you joy.
You know how important getting enough restorative sleep is for facing each new day refreshed and ready to take on the world. Now research suggests that your sleep position may have an impact on brain health, too.
ReplyDeleteFor a study done on animals, researchers used dynamic contrast magnetic resonance imaging to see the brain's glymphatic pathway. That's the system that clears waste and other harmful chemicals from the brain, much like the way the lymphatic system clears waste from organs.
The researchers found that brain waste was cleared most effectively when sleeping on one side rather than on the back or stomach. This means that side sleeping could help reduce the risk of Alzheimer's, Parkinson's and other brain-based diseases. That's because a buildup of brain waste likely plays a part in these illnesses.
Many people naturally sleep on their side already. The researchers hypothesize that humans have adapted to this position over time precisely because it helps rid the brain of the waste that builds up during waking hours. While they caution that this type of MRI study needs to be done on people to confirm their initial findings, if you're a tummy or back sleeper, you may want to consider readjusting your sleep position.
Four out of 10 people sleep not only on one side, but also in the fetal position, with torso hunched and knees bent, according to the National Sleep Foundation. The foundation cautions people not to sleep in too tight a fetal position, however, because doing so could restrict breathing.
And tummy sleepers should know that this position can lead to neck and back pain, numbness and tingling because of pressure put on joints and muscles.