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Articles
Example medicines to prescribe by brand name in primary care
27 March 2022Prescribe certain medicines by brand to ensure supply of the same product. Examples are grouped by therapeutic area. The list of products is not exhaustive.
Safety in Lactation: Sympathomimetics for acute cardiac conditions
4 November 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Dobutamine, dopamine and dopexamine are inotropes…
What is the clinical significance of potential drug interactions with local anaesthetic preparations used in primary care dentistry?
30 July 2020This updated Medicines Q&A explores the clinical significance of potential interactions between dental local anaesthetic preparations and other medicines as listed in the BNF and…
Lactation Safety Information
For allergic emergencies
For allergic emergencies
-
No published evidence of safety
Low levels anticipated in milk due to very short half-life (2 minutes)
Minimal absorption from the infant’s GI tract
Considered safe for short-term emergency use
29 July 2020
For cardiopulmonary resuscitation
For cardiopulmonary resuscitation
-
No published evidence of safety
Low levels anticipated in milk due to very short half-life (2 minutes)
Minimal absorption from the infant’s GI tract
Emergency use for CPR supercedes all other considerations
29 July 2020
New Medicines
neffyAnaphylaxis - intranasal formulation
Information
neffy
New formulation
Recordati
ARS Pharmaceuticals
Development and Regulatory status
None
Filing withdrawn
Pre-registration (Filed)
Oct 22Filed in US. The FDA accepted for review the New Drug Application (NDA) for neffy for the emergency treatment of allergic reactions (type I) including anaphylaxis in adults and children ≥30 kg (66 lbs). If approved by the FDA, neffy would be the first non-injectable treatment available to patients with allergic reactions (type I) including anaphylaxis. Prescription Drug User Fee Act (PDUFA) target action date is in mid-2023 [8].
Apr 22ARS withdraw EU filing following CHMP’s request for additional information and data. The company intend to submit a new application that addresses the requests [7].
Aug 21ARS Pharmaceuticals Raises $55 Million for Launch Preparations of Neffy. The funds will advance Neffy™ through approval, support initial launch activities and evaluate Neffy in clinical studies for additional indications [5].
Nov 20ARS announces acceptance of MAA submission by EMA. The MAA submission includes data from multiple clinical studies showing that 1 mg of Neffy achieves epinephrine exposures that are similar to a 0.3 mg epinephrine IM injection, with rapid absorption and clinical response based on surrogate endpoints. A dosage strength of 0.65 mg is under development for children weighing between 15kg and 30kg and is expected to be filed shortly after the initial approval [3].
Sep 20ARS Pharmaceuticals has entered an exclusive licensing agreement with Recordati) for marketing rights for ARS-1 in the EU, UK and several other countries [3].
Feb 19Granted fast track status in US [2].
Category
Alpha and beta adrenergic receptor agonist
The number of people who experience severe systemic allergic reactions is increasing. In the UK, incidence is about 1-3 reactions per 10,000 population per annum [1].
Anaphylaxis - intranasal formulation
Intranasal
Trial or other data
Oct 22The NDA submission to the FDA is based on data from four primary registration studies supporting that a 2 mg intranasal dose of neffy met all clinical endpoints recommended by regulators and that its pharmacokinetics were within the range of approved epinephrine injection products. These data included studies in adults, with self-administration and caregiver administration, as well as in children with Type I allergies ≥30 kg (66 lbs). In addition, neffy has been well-tolerated to date with more than 500 individuals receiving at least one dose, and many with repeat administration. The majority of adverse events in clinical trials were mild in nature without any meaningful nasal irritation or pain [8].
Sep 21The company anticipated 60% of epinephrine pen users will switch to Neffy immediately and 80% within two years [4].
Aug 21PI trial to evaluate the pharmacokinetics of epinephrine intranasal spray in patients with upper respiratory tract infections starts recruiting (NCT04930900). The two-treatment, open-label, sequential, crossover trial intends to enrol 12 patients aged 18-55 years in Australia. Completion of primary outcome data expected Oct 2021 [6].
Jun 19ARS announce topline results from EPI-04 study (n=36). Study demonstrates intranasal adrenaline spray has a similar pharmacokinetic profile to IM adrenaline in patients with allergic rhinitis, however, the former showed a faster time to peak exposure [2].