HJNO Sep/Oct 2024

36 SEP / OCT 2024  I  HEALTHCARE JOURNAL OF NEW ORLEANS   Healthcare Briefs FDA Approves First Nasal Spray for Treatment of Anaphylaxis Today, the U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphy- laxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds). “Today’s approval provides the first epineph- rine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, MD, PhD, Associate Director of the Division of Pulmonol- ogy, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research. “The availabil- ity of epinephrine nasal spray may reduce barri- ers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need.” Allergic reactions happen when a person’s immune system reacts abnormally to a sub- stance that normally does not cause symptoms. Anaphylaxis is a severe, life-threatening allergic reaction that typically involves multiple parts of the body and is considered a medical emergency. Common allergens that can induce anaphylaxis include certain foods, medications and insect stings. Symptoms usually occur within minutes of exposure and include, but are not limited to, hives, swelling, itching, vomiting, difficulty breath- ing, and loss of consciousness. Epinephrine is the only life-saving treatment for anaphylaxis and has previously only been available for patients as an injection. Neffy’s approval is based on four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of neffy or approved epinephrine injection products. Results from these studies showed comparable epineph- rine blood concentrations between neffy and approved epinephrine injection products. Neffy also demonstrated similar increases in blood pressure and heart rate as epinephrine injection products, two critical effects of epinephrine in the treatment of anaphylaxis. A study of neffy in children weighing more than 66 pounds showed that epinephrine concentrations in children were similar to adults who received neffy. Neffy is a single dose nasal spray adminis- tered into one nostril. As with epinephrine injec- tion products, a second dose (using a new nasal spray to administer neffy in the same nostril) may be given if there is no improvement in symptoms or symptoms worsen. Patients may need to seek emergency medical assistance for close monitor- ing of the anaphylactic episode and in the event further treatment is required. Neffy comes with a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect absorption of neffy, and patients with these conditions should consult with a healthcare professional to consider use of an injectable epinephrine product. Neffy also comes with warnings and precautions about use of epi- nephrine by people with certain coexisting condi- tions and allergic reactions associated with sulfite. The most common side effects of neffy include throat irritation, tingling nose (intranasal pares- thesia), headache, nasal discomfort, feeling jittery, tingling sensation (paresthesia), fatigue, tremor, runny nose (rhinorrhea), itchiness inside the nose (nasal pruritus), sneezing, abdominal pain, gum (gingival) pain, numbness in the mouth (hypoes- thesia oral), nasal congestion, dizziness, nausea, and vomiting. DCHC Celebrates Opening of NewAlgiers Location DePaul Community Health Centers (DCHC) celebrated the opening of its new, 20,ooo square foot health center, located at 2801 Gen- eral DeGaulle Drive in Algiers with a ribbon cut- ting ceremony on Aug. 9. The new health cen- ter brings imaging, urgent care services, primary and preventive care, optometry, and more to the Westbank of New Orleans community. Retired local TV news anchor, Sally-Ann Roberts, served as MC for the event. DCHC’sPresident and CEO Michael Griffin, MSPH, DSc, FACHE, and Ascension’s Senior Vice President and Chief Com- munity Impact Officer, Stacy Garrett-Ray, MD, MPH, MBA, highlighted the significance of the new health center and the need to meet patients where they are. New Orleans Archbishop Gregory Aymond opened the event with a prayer and blessed the new health center. Louisiana District 102 Representative Delisha Boyd, New Orleans City Councilman Freddie King III of District C, and National Association of Community Health Cen- ters board member and chief operating officer and compliance officer with the Health and Well- ness Center in Oklahoma, Brook Latitimore, pro- vided remarks. New Orleans District D Council- man Eugene Green was in attendance and U.S. Congressman Troy A. Carter, Sr. provided remarks virtually. Ascension’s Vice President of Commu- nity Health Ministries, Colene Daniel, was also in attendance Tulane Study Says New Drug Shows Promise in Clearing HIV fromBrain An experimental drug originally developed to treat cancer may help clear HIV from infected cells in the brain, according to a new Tulane Univer- sity study. For the first time, researchers at Tulane National Primate Research Center found that a cancer drug significantly reduced levels of SIV, the non- human primate equivalent of HIV, in the brain by targeting and depleting certain immune cells that harbor the virus. Published in the journal Brain , this discovery marks a significant step toward eliminating HIV from hard-to-reach reservoirs where the virus evades otherwise effective treatment. “This research is an important step in tackling brain-related issues caused by HIV, which still affect people even when they are on effective HIV medication," said lead study author Woong-Ki Kim, PhD, associate director for research at Tulane National Primate Research Center. "By specifi- cally targeting the infected cells in the brain, we may be able to clear the virus from these hidden areas, which has been a major challenge in HIV treatment." Antiretroviral therapy (ART) is an essential com- ponent of successful HIV treatment, maintaining the virus at undetectable levels in the blood and transforming HIV from a terminal illness into a manageable condition. However, ART does not completely eradicate HIV, necessitating lifelong treatment. The virus persists in "viral reservoirs" in the brain, liver, and lymph nodes, where it remains out of reach of ART. The brain has been a particularly challenging