Latest news with #nasalspray
Daily Mail
5 days ago
- Health
- Daily Mail
First needle-free treatment for life-threatening allergic reactions will be made available in the UK as a nasal spray
The first needle-free treatment for life-threatening allergic reactions will be made available in the UK as a nasal spray. The medicines regulator has approved the drug EURneffy for emergency use in a move welcomed by allergy campaigners. They say it provides an 'easier and more accessible' alternative to injectable epipens, which are currently used to treat severe reactions, known as anaphylaxis. Companies are required by law to clearly tell customers if their food contains any of 14 specified allergens, which have the potential to kill. These include nuts, crustaceans, eggs, fish, milk, mustard and sesame. Some people also suffer fatal reactions to insect stings and medicines. Tanya Ednan-Laperouse, whose daughter Natasha died in 2016 after eating a Pret baguette containing sesame, said: 'The number of people experiencing anaphylaxis triggered by food has increased dramatically over the last 20 years. 'But we know that some people are reluctant to use the current adrenaline auto-injectors in the event of anaphylaxis due to a fear of needles and hurting someone. 'This can delay administering adrenaline, and in a food allergy emergency every second counts. 'The nasal spray will be an easier and more accessible way of administering this life-saving medication, and is great news for people living with food allergies.' Mrs Ednan-Laperouse, who founded food allergy charity the Natasha Allergy Research Foundation in her daughter's name, added: 'Spare supplies of these nasal adrenaline devices should now be another option available to schools.' The Food Standards Agency says up to 2 per cent of adults and 8 per cent of children in the UK live with a food allergy. Anaphylaxis is a sudden and life-threatening allergic reaction that can cause a drop in blood pressure and breathing difficulties. More than 7,000 birth certificates a year in the mention anaphylactic shock, according to the Office for National Statistics. EURneffy, which contains adrenaline, is intended for use in adults and children who weigh 30kg (66lb) or more, and can be used even if people have colds or blocked noses. It is a single dose nasal spray that delivers its entire contents (2mg) upon activation. People are reminded the plunger should not be pressed before inserting the product into the nostril, otherwise the single dose will be lost. Julian Beach, from the Medicines and Healthcare products Regulatory Agency, said: 'Patient safety is our top priority, which is why we're pleased to approve the first needle-free nasal spray formulation of adrenaline for the emergency treatment of anaphylaxis in the UK. 'Until now, adrenaline for self-administration has only been available via auto-injectors. 'While this represents an important new option, adrenaline auto-injectors remain a vital and potentially life-saving treatment, giving people experiencing anaphylaxis valuable time before emergency help arrives. 'We continue to encourage everyone at risk of severe allergic reactions, and those around them, to familiarise themselves with how to respond in an emergency. 'Resources and guidance are available on the MHRA website to help people be prepared.' The MHRA said patients should always carry two nasal sprays with them in case a second dose is needed, and tell family and friends where it is. A spokeswoman for the drug firm behind the spray, ALK, said: 'The market launch in the UK is expected within the coming months once market access negotiations are completed.' ALK is having ongoing discussions to agree a price with the Department of Health and Social Care. Once an NHS list price has been agreed and the product is available, doctors will be able to prescribe the nasal spray.
Medscape
5 days ago
- Health
- Medscape
MHRA Approves UK's First Nasal Spray for Anaphylaxis
An adrenaline nasal spray for the emergency treatment of anaphylaxis has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). This marks the first time a needle-free formulation is available in the UK for this use. The spray, called EURneffy, is manufactured by ALK-Abelló A/S, a pharmaceutical company based in Denmark. It was authorised for use in the European Union in August 2023. UK approval followed the MHRA's International Recognition Procedure, introduced in January 2024. The pathway enables the MHRA to align with decisions made by trusted global regulatory partners. Alternative to Adrenaline Auto-Injectors Adrenaline is the standard emergency treatment for anaphylaxis and is usually administered by auto-injectors pens. EURneffy is the first approved nasal spray alternative. The ready-to-use spray is suitable for adults and children weighing 30 kg (about 66 lbs) or more. It delivers its entire contents of 2 mg of adrenaline with a single activation, even when the user has nasal congestion. It is indicated for the emergency treatment of allergic reactions caused by insect stings or bites, foods, medicinal products, and other allergens. It can also be used to treat idiopathic or exercise-induced anaphylaxis. According to ALK-Abelló, the product offers a 30-month shelf life and better temperature stability compared with traditional adrenaline auto-injectors. Patients Should Always Carry Two Doses Patients are advised to carry two doses of adrenaline in case a second dose is needed. A second dose should be given in the same nostril after 10 minutes if symptoms persist or recur. Patients should also inform friends or family about their condition in case help is needed during a reaction. Biphasic anaphylaxis — a delayed recurrence of symptoms — remains a risk. Patients should seek immediate medical attention after any severe allergic reaction, regardless of whether symptoms resolve. The MHRA cautioned that the spray's plunger must not be pressed before insertion into the nostril, as this will release the single dose prematurely. Efficacy and Tolerability Supported by Trial Data Presentations at the European Academy of Allergy and Clinical Immunology congress last month in Glasgow highlighted that Eurneffy nasal adrenaline spray addressed "unmet needs and current challenges in the emergency management of anaphylaxis". Ethical and practical constraints prevent trials in patients experiencing acute anaphylaxis. However, data from ALK-Abelló's development programme, involving more than 700 participants, demonstrated that the spray produced a pharmacological response comparable with that of intramuscular adrenaline auto-injectors. Real-world data also supported the effectiveness of the nasal adrenaline spray in acute situations. No serious adverse events were reported in clinical studies. The most frequently occurring adverse reactions were reported only after a second 2 mg dose (4 mg total). These included throat irritation (18.8%), headache (17.6%), nasal discomfort (12.9%), and feeling jittery (10.6%). Ongoing Safety Monitoring The MHRA will continue to monitor the safety and effectiveness of Eurneffy. Healthcare professionals and patients are urged to report suspected side effects through the Yellow Card scheme. Further information, including the Patient Information Leaflet and Summary of Product Characteristics, will be available on the MHRA website within seven days of approval.
Telegraph
5 days ago
- Health
- Telegraph
First nasal spray for allergic reactions now available in UK
The first needle-free emergency treatment for anaphylaxis – in the form of a nasal spray – will now be available in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the adrenaline (epinephrine) nasal spray (EURneffy) for emergency treatment. The manufacturer, ARS Pharma, has been contacted for comment about whether it plans to seek wider approval for use on the NHS. Julian Beach, MHRA interim executive director of healthcare quality and access, said: 'Patient safety is our top priority, which is why we're pleased to approve the first needle-free nasal spray formulation of adrenaline for the emergency treatment of anaphylaxis in the UK. 'Until now, adrenaline for self-administration has only been available via auto-injectors. 'While this represents an important new option, adrenaline auto-injectors remain a vital and potentially life-saving treatment, giving people experiencing anaphylaxis valuable time before emergency help arrives. 'We continue to encourage everyone at risk of severe allergic reactions, and those around them, to familiarise themselves with how to respond in an emergency. 'Resources and guidance are available on the MHRA website to help people be prepared.' Anaphylaxis is a sudden and life-threatening allergic reaction that can cause a drop in blood pressure and breathing difficulties. EURneffy is intended for use in adults and children who weigh 30kg (about 66lb) or more, and can be used even if people have colds or blocked noses. It is a single dose nasal spray that delivers its entire contents (2mg) upon activation. People are reminded that the plunger should not be pressed before inserting the product into the nostril, otherwise the single dose will be lost. The MHRA said patients should always carry two nasal sprays with them in case a second dose is needed, and tell family and friends where it is.
The Guardian
5 days ago
- Health
- The Guardian
Hay fever making the summer of ‘25 sneezy? We're here to help
When the sun's shining and you're itching to join in at festivals, picnics and outdoor fun, a nasal spray could turn your summer from 'meh' to 'mega' Buy Beconase now on Amazon Beconase Hayfever Relief for Adults 0.05% Nasal Spray contains beclometasone dipropionate. For the treatment of hayfever and symptomatic relief from nasal congestion, runny nose, sneezing, itchy nose, eye symptoms (such as itching, watering, redness) and associated sinus discomfort in adults aged 18 and over. Always read the leaflet. MAT-9522
Daily Telegraph
30-06-2025
- Business
- Daily Telegraph
LTR Pharma completes ED study milestone
Don't miss out on the headlines from Stockhead. Followed categories will be added to My News. LTR Pharma & co-development partner Aptar Pharma complete extractables study on SPONTAN All identified compounds below ICH safety thresholds for nasal spray-mist erectile dysfunction treatment Leachables study initiated to support FDA regulatory submission under real-world storage conditions Special Report: LTR Pharma has completed a key extractables study for its SPONTAN intranasal spray for erectile dysfunction and kicked off a leachables study as part of a regulatory development program. LTR Pharma (ASX:LTP) said the extractables study, conducted under the supervision of co-development partner Aptar Pharma, evaluated the bottle and pump components of SPONTAN's container closure system. The study confirmed that all detected compounds were below ICH safety thresholds – the internationally recognised standards adopted by the US Food and Drug Administration (FDA) and regulatory authorities worldwide for pharmaceutical impurities. LTR Pharma said the identified compounds would be monitored in the ongoing leachables study. FDA requires extractables and leachables (E&L) studies for all pharmaceutical products to ensure packaging materials do not compromise product safety or efficacy. For nasal spray products, these studies must meet specific regulatory thresholds due to direct tissue exposure. Leachables study now underway The leachables study has started under Aptar Pharma's management, evaluating the potential migration of the compounds from packaging into SPONTAN under real-world storage conditions. LTR Pharma said SPONTAN used industry-standard bottle and pump components as used in multiple FDA-approved nasal spray products. The study will run for at least 24 months to support shelf-life requirements. Consistent with FDA practice for nasal sprays, the company can submit its application once sufficient robust data is available, with study completion continuing post-approval as standard. E&L studies form part of LTR Pharma's comprehensive regulatory strategy following its FDA pre-IND meeting, where the FDA confirmed the proposed development pathway. The company said E&L data were required for the chemistry, manufacturing and controls (CMC) section of its planned new drug application (NDA). With extractables results meeting regulatory requirements, the company progresses to the leachables phase for comprehensive regulatory submission data. Watch: LTR's new appointment Progress on SPONTAN and new US-targeted ROXUS LTR Pharma continues to progress SPONTAN through established regulatory pathways while building commercial foundations through its Australian early access programs. It is also progressing its new ED nasal spray called ROXUS, which offers a fast-track pathway to serve patients through the US personalised healthcare sector. As with SPONTAN, ROXUS is based on the common active ingredient vardenafil. It will be delivered via the 503(a)-compounding pharmacy pathway, which exempts drugs from the usual approval, labelling and manufacturing requirements. "The completion of our extractables study and commencement of the leachables phase keep our regulatory program on schedule,' LTR Pharma executive chairman Lee Rodne said. 'Working with Aptar Pharma provides us with their established expertise in nasal spray device development and FDA submissions. 'These studies are necessary steps in our development pathway, and we look forward to progressing through each regulatory milestone." This article was developed in collaboration with LTR Pharma, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions. Originally published as LTR Pharma completes study milestone for SPONTAN ED treatment
