Novel new depression drugs receive FDA approval
As rates of depression continue to climb in the U.S., two completely new types of drugs to treat it – specifically, for adults whose serious depression fails to respond to other medications and for new mothers suffering from postpartum depression – recently received limited-use approval from the U.S. Food and Drug Administration [FDA].
The first, to be marketed under the brand name Spravato, is a nasal spray form of esketamine, which is related to the anesthetic and “party drug” ketamine. Spravato is to be used in conjunction with an oral antidepressant in adults who have tried other medications which have failed to help their depression. It is currently available on a restricted basis only, to be administered in a healthcare facility under close monitoring, and patients will not be able to take it home due to a risk of hallucinations or other significant side effects.
Esketamine works in the brain in a completely different way than any previous antidepressant. And unlike other drugs which may take weeks or months to work, esketamine nasal spray has been shown to reduce severe depression symptoms, including suicidal thoughts, very quickly – within hours to days for many. Because it is so fast-acting, esketamine has been heralded by many mental health care professionals as a life-saving drug.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.
The FDA granted its approval for Spravato through its FastTrack and Breakthrough Therapy designations program.
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A second antidepressant medication called brexanolone, which specifically targets postpartum depression [PPD] in women, also has just received FDA approval. The drug, to be marketed under the brand name ZULRESSO™, will be given to patients by injection. Similar to esketamine, it will be administered only under supervision in a healthcare setting because of the risk of side effects.
This new drug could be a game-changer in women’s health, according to researchers involved in the clinical trial process prior to its approval. “Given the results of the ZULRESSO clinical trials, we believe that this will be an important treatment option which could provide relief for women with PPD, a disorder with a range of postpartum severity,” said Dr. Samantha Meltzer-Brody, the academic principal investigator of the trials.
Brexanolone also works differently than existing antidepressant medications, and has been shown to help many women feel better within days of having an injection. It is the first FDA-approved drug specifically indicated for PPD.
The mood disorder, which is triggered by fluctuations in reproductive hormones, produces symptoms including low mood, feeling overwhelmed, anxious and ruminating thoughts, potential withdrawal from the baby and a new mother’s own family, and suicidal thoughts in the most severe of cases.
PPD is one of the most common complications of pregnancy; about one in nine women in the U.S. experiences symptoms after giving birth, according to the Centers for Disease Control and Prevention.
To recognize signs of a stroke, BEFAST
Nearly 800,000 Americans suffer a stroke every year. That statistic averages out to one person every 40 seconds – and when strokes happen, every second truly is critical. Getting stroke victims to an emergency room as early as possible both improves their odds for survival and increases their chances of making a full recovery.
During Stroke Awareness Month each May, Americans are reminded to be watchful for the most common symptoms of stroke in both men and women. Experiencing any one of these symptoms, or noticing any of them in a friend or loved one, warrants an immediate call to 911. They include the sudden onset of numbness or weakness in the face, arm, or leg, especially on one side of the body; confusion, trouble speaking, or difficulty understanding speech; trouble seeing in one or both eyes; trouble walking, dizziness, loss of balance or lack of coordination; or a sudden very severe headache with no known cause.
The American Stroke Association currently uses the acronym F.A.S.T. – which stands for Face, Arms, Speech and Time – to quickly summarize the most common warning signs of a stroke. A growing number of medical centers and health authorities also have added two other types of symptoms, Balance and Eyes, to that summary. Following is a description of the symptoms included in that easy-to-remember acronym, B.E.F.A.S.T. Knowing it can help you take action when seconds count:
• Balance: Watch for a sudden loss of balance or trouble walking.
• Eyes: Is there a sudden loss of vision in one or both eyes? Or double vision?
• Face: Ask the person to smile. Does one side of the face droop?
• Arms: Ask the person to raise both arms. Does one arm drift downward?
• Speech: Ask the person to repeat a simple phrase. Does the speech sound slurred or strange?
• Time: If you observe any of these signs, call 911 immediately.
Clinical trial of universal influenza vaccine begins
Every year, health authorities both in the U.S. and worldwide face the challenge of predicting the predominant influenza strains which will circulate during that year’s flu season, and creating a vaccine that will be effective against them. This can be a hit-or-miss process, as was seen during the 2017-2018 flu season when a minimally effective vaccine led to a severe and widespread flu outbreak in many countries.
But as the more moderate flu season of 2018-2019 ends, the first clinical trial of a universal influenza vaccine is beginning in the U.S. The experimental vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases [NIAID], is designed to teach the body to create a protective immune response against many diverse influenza subtypes, including those that might cause a pandemic. The goal of the research is to create a “universal” influenza vaccine that can provide long-lasting protection for people of all ages.
“Seasonal influenza is a perpetual public health challenge, and we continually face the possibility of an influenza pandemic resulting from the emergence and spread of novel influenza viruses,” said NIAID Director Anthony S. Fauci, M.D. “This Phase 1 clinical trial is a step forward in our efforts to develop a durable and broadly protective universal influenza vaccine.”
Initial phases of the trial are expected to be complete by the end of 2019, and researchers hope to begin reporting results in early 2020. More information about the trial is available online at ClinicalTrials.gov [search identifier NCT03814720].
On the calendar
St. Louis Children’s Hospital sponsors a Family and Friends CPR course on Saturday, May 4 from 9-11:30 a.m. at the Children’s Specialty Care Center, 13001 N. Outer 40 Road in Town & Country. Participants are not certified, but will receive a card showing participation in the class. The cost is $25 per person. Register online at https://classes-events.bjc.org/wlp2/.
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St. Luke’s Hospital presents a Basics of Meditation course on Wednesday, May 8 from 6:30-8 p.m. at the St. Luke’s Desloge Outpatient Center, 121 St. Luke’s Center Drive, in Building A. Meditation is a research-supported practice that can improve health by reducing stress, lowering the risk for heart disease, helping to reduce pain and more. Come learn the basics and receive expert tips at this free class. Register online at stlukes-stl.com.
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St. Luke’s Hospital offers cholesterol and glucose wellness screenings on Thursday, May 9 from 7-10 a.m. at St. Luke’s Convenient Care, 1080 Lindemann Road [inside Dierbergs]. Get your cholesterol and glucose numbers in a one-on-one consultation with a registered nurse/health coach, which also includes blood pressure and body composition measurement. The cost is $20; an A1C blood test is also available for an additional $12. Advance appointments are required; register online at stlukes-stl.com.
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Mercy Hospital St. Louis offers a Home Alone course on Friday, May 10 from 6:30-8:30 p.m. at the hospital’s main campus, 615 S. New Ballas Road, in Classroom 2 on the seventh floor. Children 9-11 years of age will learn about self-care topics including personal safety and protection, basic first aid and emergency preparedness. A light snack will be provided. The course fee is $20. Register online at mercy.net [click on “Find Classes and Programs” under the Resources tab].
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St. Luke’s Hospital offers a free information session, You Can Manage It – Prevent Diabetes from Controlling Your Life, on Tuesday, May 21 from 1-2:30 p.m. at the Desloge Outpatient Center, 121 St. Luke’s Center Drive in Chesterfield. The goal of this program is to empower people living with diabetes to take charge of their health. Register online at stlukes-stl.com.
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The Missouri Botanical Garden presents a free class, Detox Your Domicile, on Thursday, May 23 from 7-8 p.m. at the Daniel Boone Library, 300 Clarkson Road in Ellisville. Learn more about the chemical dangers lurking in your home. Discover methods to evaluate product safety and create low-cost, healthier DIY alternatives to home cleaning and personal care products. Online registration is available at slcl.org/Events.
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An American Red Cross Blood Drive is on Thursday, May 23 from 11 a.m.-3 p.m. at the Daniel Boone Library, 300 Clarkson Road in Ellisville, in Meeting Rooms 2 and 3. To schedule an appointment, visit redcrossblood.org or call the Red Cross at 1-800-733-2767.