Heron Therapeutics Receives Complete Response Letter For HTX-011 For The Management Of Postoperative Pain
commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on April 30, 2019 regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.
The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional CMC and non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses.
"We plan to request a meeting with the FDA to obtain its agreement on our approach to resolve the issues outlined in the CRL and resubmit the NDA as soon as possible," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics.
About HTX-011 for Postoperative Pain
HTX-011, which utilizes Heron's proprietary Biochronomer® drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine solution in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted an NDA to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018. A CRL was received from the FDA regarding the NDA for HTX-011 on April 30, 2019. An MAA for HTX-011 was validated by the EMA in March 2019 for review under the Centralised Procedure.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. For
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ReplyDeleteA number of studies in recent years have found that cancer survivors have a relatively lower risk of developing Alzheimer's.
The new research adds another layer. It shows that even before their diagnosis, older adults who go on to develop cancer have an edge when it comes to memory performance.
Among the older Americans who were tracked for 16 years, those who developed cancer typically had sharper memory skills -- both before and after the diagnosis -- than those who remained cancer-free.
Researchers said it all supports the theory that some of the biological processes that contribute to cancer may actually protect against dementia.
But the big remaining question is, what are those mechanisms?
"We're really interested in understanding what [they] could be, because it might point the way to strategies to prevent dementia," said senior researcher Maria Glymour, a professor at the University of California, San Francisco School of Medicine.
With all the attention that the very high-fat Keto diet is getting, you might be wondering how much fat is healthy and how much your body really needs every day to thrive.
ReplyDeleteFirst, know that some fat is essential for most people. Your body uses fat for many health functions, including processing fat-soluble vitamins like A and E. Including some fat in meals helps you feel more satisfied, and that's important when you're eating fewer calories on a weight-loss diet and want to curb between-meal hunger.
As for ideal amounts, healthy adults should eat between 20% and 35% of their calories from fat, according to the Academy of Nutrition and Dietetics. Keep in mind that one tablespoon of olive oil is equal to 10% of the daily calories in a typical, 1,200-calorie per day weight-loss diet.
To calculate a more personal daily range of fat grams, the American Council on Exercise suggests a simple formula. For the minimum amount, multiply your weight (in pounds) by 0.4 and for the maximum, multiply it by 0.5. So, if you weigh 140 pounds, that's between 56 and 70 grams of fat each day.
What kinds of fats you eat matter, too. Most should be from mono- and polyunsaturated fat foods. Limit saturated fats and avoid trans fats altogether. Trans fats are being phased out of packaged foods, but you might still see items on shelves until 2020, so read ingredient labels carefully.
Main Sources of Key Fats
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Polyunsaturated fats: fatty fish such as trout, herring and salmon; walnuts; flax, pumpkin, sesame and sunflower seeds; sunflower, corn and soybean oils.
Saturated fats: butter, lard, coconut and coconut oil, cocoa butter, palm oil and palm kernel oil; meat, poultry and full-fat dairy.
Trans fats: typically partially hydrogenated oils found in packaged goods from non-dairy creamers to some microwave popcorn.
A 32-year Harvard study found that replacing just 5% of saturated fat calories with polyunsaturated ones delivers important health benefits. An easy switch is replace two servings of red meat each week with a fatty fish.