Gwen Smith’s Post

AllergyStrong is disappointed in the FDA's decision to decline approval for Neffy, a nasal epinephrine. Epinephrine is the only medicine that can stop severe allergic reaction (anaphylaxis). But patients, caregivers, schools and others cite fear of the needle and fear of negative side effects as reasons for not filling prescriptions or administering this life-saving medication when it's most needed. Delays in delivering epinephrine can result in worse patient outcomes, such as escalating serious life-threatening symptoms, more medication, and longer treatment time. The food allergy community needs needle-free administration of epinephrine to help overcome this barrier and save lives. Nasal epinephrine fills a critical unmet need in the allergic community. #allergies #foodallergy #emergencymedicine #schoolnurses #epinephrine #anaphylaxis ARS Pharmaceuticals, Inc.

“Phenylephrine, an ingredient in popular over-the-counter cold and allergy medicines, doesn’t work, a US Food and Drug Administration (FDA) advisory committee determined Tuesday. The ingredient, a nasal decongestant, is found in brands like Benadryl, Mucinex, Sudafed, Nyquil, and Tylenol. The Nonprescription Drugs Advisory Committee (NDAC) met Sept 11-12 to discuss the latest efficacy data for orally administered phenylephrine as a nasal decongestant and whether the oral nasal decongestants phenylephrine (PE) hydrochloride and phenylephrine bitartrate should be reclassified as not Generally Recognized as Safe and Effective (GRASE) due to lack of efficacy.” I reemphasize the phrase “should be reclassified as NOT Generally Recognized as Safe and Effective (GRASE) due to lack of efficacy.” #OTCdecongestants #phenylephrine #respiratorycare

Interesting read on the importance of dosage form and formulation in pharmaceuticals! It's crucial to ensure that the medications we take are not only safe but also effective. This article highlights the recent findings that phenylephrine tablets, a common ingredient in OTC cold and allergy medicines, may not be as effective as previously thought. It's a reminder of the significance of science and research in optimizing healthcare products. #Pharmaceuticals #Healthcare #DosageForm #Formulation

FDA Grants Priority Review to Xolair (omalizumab) for Children and Adults With Food Allergies Based on Positive National Institutes of Health Phase III Study Results If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure. Interim analysis results from first-of-its-kind Phase III OUtMATCH study showed Xolair significantly increased the amount of peanut, milk, egg and cashew it took to cause an allergic reaction. Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with food allergy. If approved, people taking Xolair would still need to avoid foods they are allergic to (commonly referred to as “food avoidance”). The filing acceptance is based on positive interim analysis results from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study evaluating Xolair in patients allergic to peanuts and at least two other common foods. The FDA is expected to make a decision on approval in the first quarter of 2024. The Phase III OUtMATCH study is being sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and conducted by the NIAID-funded Consortium of Food Allergy Research (CoFAR) across 10 clinical sites throughout the U.S. The study is also supported by Genentech and Novartis Pharmaceuticals Corporation. Detailed results from the OUtMATCH study have been submitted by NIAID and CoFAR to a peer-reviewed journal. Read Genentech’s full press release: https://buff.ly/3tqJ25T #FoodAllergy #FoodAllergies #Allergy #Anaphylaxis #OUtMATCH #Research #Xolair #AllergyAwareness #FoodAllergyAwareness #FoodAllergyLife #FoodAllergyFamily #FoodAllergyResearch #FoodAllergyKids #FoodAllergyMom #FoodAllergyParent #FoodAllergyCaregiver #FAACT #ShareTheFAACTs

A drug that works doesn't mean it generates sales. Results of the peanut allergen deal goes south, a sad day for Nestle's foray into pharmaceuticals. Palforzia is a $200K per year oral tolerance capsule containing peanut allergen. In 2020 it was predicted that approval by the FDA would alter the course of peanut allergy treatment with revenues in the >$ 1Bn range, however unfortunate timing resulted in launch during Covid pandemic, and lack of access to allergy physicians to administer the drug in office. On top of that the protection afforded by Palforzia is not a complete desensitization of peanuts, but rather an attenuated response to peanuts accidentally ingested, as long as it does not exceed approximately 2 peanuts. The exact sales for for Palforzia in 2022 is not found in the Annual report, but an impairment charge of ~$1.9 Bn suggest that the vast proportion of the market value of this asset was annihilated, as it was sold off to Stallergenes. It is interesting to note that Kit-Kat has a steady brand value of ~$2.1 Bn. Perhaps Big Food is a safer sport to play rather than Big Pharm. From Biopharma Dive " * Nestlé on Monday said it sold the peanut allergy treatment Palforzia to Swiss company Stallergenes Greer, abandoning the therapy three years after acquiring it in a $2.6 billion deal. * Developed by the biotechnology company Aimmune Therapeutics, Palforzia won Food and Drug Administration approval in 2020. The clearance spurred some debate as treatment led to allergic reactions in participants involved in its testing, but Nestlé saw a market opportunity and later that year bought the rest of Aimmune that it didn’t already own. * Palforzia never caught on, however, and sales remained slow. Late last year, Nestlé admitted it was reviewing options for the business and subsequently wrote down much of Aimmune’s value." ---- The views expressed here are of the Author only. https://lnkd.in/dJEuDDME

A Food and Drug Administration (FDA) advisory committee met about the drug phenylephrine. The committee voted that data does NOT demonstrate that oral versions are effective to treat nasal congestion. The FDA will now decide whether it will allow the medicine to continue to be sold in oral form. https://lnkd.in/gcDkxyjn If the FDA reclassifies oral phenylephrine, the drug will no longer be sold in oral form as a nasal decongestant. That means many popular OTC oral cold and allergy medicines will no longer be sold. This may be concerning for people with nasal allergies. Nasal decongestants, used for a short time period, can be part of a treatment plan for allergic rhinitis and colds. People who currently rely on an oral medicine that contains phenylephrine should talk with their doctor about other more effective treatment options. (And remember, decongestants should only be used for one to three days.)

New article in Drugs in Context How to handle off-label prescriptions of rupatadine, a second-generation antihistamine and PAF antagonist: a review Iñaki Izquierdo Pulido, Laia Casas, Susana Cabrera, Alberto Fernandez Review the off-label use of rupatadine (a second-generation antihistamine with PAF antagonist activity) in combination with immunotherapy in the treatment of food allergy or allergic rhinitis, at high doses in chronic urticaria, and with prescriptions of less common but challenging conditions such as skin pruritus or mast cell activation disorders like mastocytosis with the aim of increasing compliance and achieving better results in clinical practice. #drugsincontext #antihistamines #allergies #urticaria #clinicalpractice #clinicalpharmacy #pharmacology #offlabel https://lnkd.in/d64wZExB

"It is well established that when mast cells, a type of immune cell, mistake a harmless substance, such as peanuts or dust mites, as a threat, they release an immediate first wave of bioactive chemicals against the perceived threat. "When mast cells, which reside under the skin, around blood vessels and in the linings of the airways and the gastrointestinal tract, simultaneously release their pre-stored load of bioactive chemicals into the blood, instant and systemic shock can result, which can be lethal without quick intervention. "More than 10% of the global population suffers from food allergies, according to the World Health Organization (WHO). As allergy rates continue to climb, so does the incidence of food-triggered anaphylaxis and asthma worldwide. In Singapore, asthma affects one in five children while food allergies are already the leading cause of anaphylactic shock. "As reported in the journal Nature Immunology, the researchers from Duke-NUS have now discovered is that the release of particulate mast cell granules, which contain these bioactive chemicals, is controlled by two members of an intracellular multiprotein complex called inflammasome. Until now, researchers only knew these inflammasome proteins to spontaneously assemble within immune cells to secrete soluble chemicals to alert other parts of the immune system upon detection of an infection." #allergies

CNN HEALTH-weekly newsletter-Popular OTC medicines for colds and allergies don’t work, FDA panel says Phenylephrine, a popular ingredient in many over-the-counter allergy and cold medicines, is ineffective in tablet form, an independent advisory committee to the US Food and Drug Administration has decided. Phenylephrine is the main ingredient used in products like Benadryl Allergy Plus Congestion, Sudafed PE and Vicks Sinex. It’s considered the most common ingredient in over-the-counter oral, nasal and sinus products, according to the American Academy of Allergy, Asthma and Immunology. Last year, the group supported a citizens petition to remove the drug’s over-the-counter status. The ingredient is considered safe to use; that was not up for debate by the FDA committee. But many doctors have questioned phenylephrine’s effectiveness for years. In pill form, some scientists say, phenylephrine gets absorbed by the gut and is metabolized so well that only a tiny bit makes it to the bloodstream, where it is needed to reach the nose, according to the citizen petition that asked the FDA to pull the drug from store shelves. “We really should not have products on the market that are not effective,” said committee member Dr. Diane Ginsburg of the University of Texas at Austin College of Pharmacy. After the committee vote, the FDA reminded the public that it has the final say in whether phenylephrine will remain on shelves. If the FDA decides that oral phenylephrine is not effective, it will issue a proposed order removing it from the Generally Recognized as Safe and Effective category and then give the public a chance to comment. If the FDA still concludes that the ingredient isn’t effective, it will issue a final order and take it off the GRASE list. Spray forms of the medication would not be affected. “FDA would then work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies,” the agency said. If phenylephrine is no longer available, there are several other OTC options including nasal spray antihistamines, nasal corticosteroids and nasal saline products, as well as tablets with pseudoephedrine.

Pleased to share that we have entered the UK consumer health market with the launch of allergy medication Histallay (Fexofenadine Hydrochloride 120 mg tablets). We are already one of the largest producers of Fexofenadine Hydrochloride (the active pharmaceutical ingredient in Histallay), the most dispensed antihistamine in the UK*. Our Fexofenadine 120 mg was previously classified as a Prescription Only Medicine (POM). With Histallay’s introduction, our Fexofenadine 120 mg is now available without prescription. That means people with allergic seasonal rhinitis (hayfever) have direct access to the product via retail outlets such as pharmacies and supermarkets in the UK. Histallay is our first GSL product in the UK market.   Entering consumer healthcare is a logical step for us and true to our purpose of offering more choices for customers and patients. Our expertise in the allergy segment has already allowed us to become a leader in the UK’s prescription fexofenadine market. By making Histallay available over the counter, we enable allergy sufferers to get faster access to treatment and better control over their symptoms since early treatment is key. Visit here: https://lnkd.in/dSxtB9c4 #DrReddysEurope #GoodHealthCantWait #WeAreDrReddys #DrReddysXSustainability    *IQVIA Antihistamines prescription market 2022. #1 UK antihistamine, by volume of packs dispensed during Jan 23-July 23, as per the volume market report by IQVIA. IQVIA report extract: ‘Antihistamine R06A total fexofenadine 120mg 30 tablets pack volume dispensed in the UK market’ as accessed on 26.10.2023’