Clinical Trials

Still Seeking Volunteers to Join a Clinical Trial for Peanut Allergy

The on-going Phase 3 VITESSE Clinical research study is looking to determine the efficacy of an investigational drug patch in children aged 4-7 with Peanut Allergy. The study has already enrolled over 400 children and is in the final months of identifying the last volunteers to complete the study.
Participation is completely voluntary, and if you are eligible and choose to enroll, your family will be potentially helping others with peanut allergy by contributing to medical research.

Visit www.vitesseallergystudy.com to check eligibility criteria and gain more insights into the VITESSE Phase 3 study. Please reach out to the closest clinical site to you to get your child enrolled to this important study.

Study sponsored by DBV Technologies

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Latest Food Allergy News

Anaphylaxis

FDA Approves neffy® Epinephrine Nasal Spray for Treating Severe Allergic Reactions
On Aug. 9, 2024, the Food and Drug Administration (FDA) approved neffy®, an epinephrine nasal spray to treat anaphylaxis, a severe allergic reaction, in adults and children who weigh at least 30 kilograms (about 66 pounds).

Neffy is a single-dose nasal spray to be given in 1 nostril. You can give a second dose (using a new nasal spray to administer neffy in the same nostril) if symptoms don’t get better or get worse. You may need to get emergency medical care to monitor the allergic reaction in case you need more treatment.Until now, epinephrine has only been available in devices that use needles. A nasal spray gives people managing allergies more options. On Sept. 19, 2023, the FDA requested another study on neffy. The approval comes following the completion of that study, focused on adults. A study of neffy in children weighing more than 66 pounds showed that epinephrine concentrations in children were similar to adults who received neffy.

Epinephrine nasal spray may remove some of the barriers that prevent people from using epinephrine. The needle-free device removes the fear of needle-based injections and may be easier to use. This may increase confidence among people managing life-threatening allergies.

Food Allergy

FDA Approves Palforzia® Oral Immunotherapy for the Treatment of Peanut Allergy in Younger Children
Peanut allergy affects about 2% of people in Western countries. The number of children with a peanut allergy doubled between 2005 and 2015. Compared to other food allergies, peanut allergy has higher rates of accidental exposure and severe allergic reactions (anaphylaxis). This risk can increase the burden of people living with peanut allergy.

Stallergenes Greer recently announced that the FDA has approved Palforzia for treating peanut allergies in children aged 1 to 3 years. It was previously approved for children aged 4 to 17 in 2020. Palforzia is an oral immunotherapy (OIT) that works by delivering measured doses of peanut powder in daily capsules. The dose will be increased every few weeks under the supervision of an allergist. Over time, the treatment may improve tolerance and reduce the risk of severe allergic reactions to peanut.

The FDA’s decision was based on a Phase 3 study called POSEIDON, which found that Palforzia was both safe and effective for young children with peanut allergies. This approval aims to meet the high need for treatment options in this age group, helping to reduce the burden of peanut allergies on families.

Parents' Experiences Giving Epinephrine for Allergic Reactions During Infant and Toddler Oral Food Challenges
Oral food challenges (OFCs) are used to test if a person with a suspected food allergy can safely tolerate a food. During an OFC, a health care provider gives the patient the suspect food in measured and increasing doses over a set amount of time. The staff monitors the signs and symptoms of an allergic reaction closely. Oral food challenges are the gold standard for diagnosing food allergy.

A recent study focused on parents' experiences when giving their young child an epinephrine auto-injector during an OFC if the child had a serious allergic reaction. The study included 343 infants and toddlers. Of the 343 children, 9 of them needed epinephrine during their OFC. The parents were trained beforehand on how to use an epinephrine auto-injector by a member of the study team who also provided supervision and support. After the OFC, parents shared their experiences through surveys and interviews.

Three main findings emerged:

1. Parents generally found the experience of giving the epinephrine auto-injector to be positive and they felt it was helpful, even though it was stressful.
2. Parents gained confidence in both recognizing signs of a severe allergic reaction and when and how to safely administer an epinephrine auto-injector if needed.
3. Parents wanted more specific information on what to do after a positive OFC.

In summary, parents found the experience of administering an epinephrine auto-injector during an OFC to be helpful and positive even though their child had a severe allergic reaction. The study suggests that while parents can feel anxious during an OFC, they also feel more capable after the experience. But, it also highlights the need for better support and education for parents after an OFC, especially if their child has a reaction. The findings can help guide future research and should improve parent support both during and after OFCs.

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