Your source for the latest industry trends and drug information news.
Volume 6 | Issue 17
September 1, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On August 9, 2024, the U.S. Food and Drug Administration (FDA) approved neffy® nasal spray, the first needle-free form of epinephrine for emergency treatment of allergic reactions, including anaphylaxis. It is approved for use in adults and pediatric patients weighing at least 66 pounds. Anaphylaxis is a severe type of allergic reaction that occurs rapidly after exposure to an allergen and can be life threatening if treatment is not administered in a timely manner. Individuals experiencing anaphylaxis may present with hives, swelling, itching, difficulty of breathing and/or loss of consciousness. The only other treatments for anaphylaxis to date have been injectable epinephrine products, such as an EpiPen. Nasal spray epinephrine provides an effective alternative for treating the life-threatening reaction in patients who are averse to needles. Developed by ARS Pharmaceuticals, neffy® is a single-dose nasal spray that is administered into one nostril. A second dose, using a new nasal spray device, can be administered into the same nostril if there is no improvement in symptoms.
The approval of the nasal spray is based on four studies involving 175 adults without anaphylaxis. Epinephrine blood concentrations were evaluated following neffy® administration versus an epinephrine injection. The results showed similar epinephrine concentrations between both products. Neffy® also demonstrated comparable increases in blood pressure and heart rate relative to the injectable. Another study in children over 66 pounds produced results similar to those found in the studies performed in adults.
There are warnings associated with neffy®, specifically in those with existing nasal polyps or a history of nasal surgery, as this may affect the absorption of the product. Additionally, precaution is advised in individuals with coexisting chronic conditions or allergic reactions associated with sulfite. Potential side effects of neffy® include throat irritation, nasal symptoms (tingling, itching, runniness, sneezing and congestion), headache, jitteriness and tremor.
On August 5, 2024, Baxter International Inc. issued a voluntary recall of one lot of Heparin Sodium 0.9% Sodium Chloride Injection. The recall was initiated due to the potential for elevated levels of endotoxins in the product due to bacterial contamination. Endotoxins are hazardous compounds released by bacteria that can lead to serious health effects, including fever, toxic shock, organ failure and death.
Heparin is an anticoagulant that is injected or infused to either prevent or treat blood clots. The affected product lot is N008235 with an expiration date of August 31, 2024. It was distributed to wholesalers and healthcare facilities in the United States, and, to date, there have been no reports of adverse events associated with this recall. Adverse events related to the product should be reported to FDA’s MedWatch Adverse Event Reporting program.
On August 7, 2024, Purdue Pharma announced the FDA approval of Zurnai™ (nalmefene) Auto-Injector for the emergency treatment of known or suspected opioid overdose in adults and children 12 years and older. The mainstay of treatment of opioid overdoses has been naloxone nasal spray or injection. The active ingredient in Zurnia™, nalmefene, is similar to naloxone. Both block opioid receptors in the brain to reverse the effects of opioids. However, nalmefene has a stronger bond to the receptors than naloxone, and it has a longer duration of effect. Opioid overdoses can be induced by natural opioids, such as morphine, but more recently the primary contributors have been synthetic opioids, such as fentanyl. The increase in opioid overdose deaths due to high-potency synthetic opioids has prompted the need for stronger, longer-lasting treatment options such as Zurnai™ to counteract their effects.
Zurnai™ is a single-dose auto-injector meant for administration into the outer thigh and delivers 1.5 mg of nalmefene hydrochloride under the skin or into the muscle. A prescription is required to access Zurnai™. The most common side effects associated with Zurnai™ include feeling hot, nausea, headache, dizziness, chills, pain, vomiting, heart palpitations, ringing or discomfort in the ear, feeling abnormal, burning sensation and irritability. Opioid-dependent individuals may experience opioid withdrawal after administration that could last for several hours due to its longer duration of action.
New Drug: Yorvipath® (palopegteriparatide)
Subcutaneous (under the skin) injection approved for the treatment of adults with hypoparathyroidism, a condition in which the parathyroid gland produces less parathyroid hormone, leading to low calcium levels and muscle cramps, pain and twitches. [08/12/2024-Ascendis Pharma]
New Drug: Livdelzi® (seladelpar)
Intravenous injection approved as a biosimilar to Soliris® for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce the breakdown of red blood cells, and for patients with atypical hemolytic uremic syndrome (aHUS). Both PNH and aHUS are rare blood disorders that cause destruction of red blood cells, blood clots and kidney disease.
