Home Food Allergies Advocacy and analysis – November 2022

Advocacy and analysis – November 2022

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Advocate now by finishing two surveys – one on guaranteeing epinephrine auto-injectors proceed to be accessible with no prescription, and one other on meals allergy and airline journey. Take a look at what’s new in meals allergy analysis, from needle-free epinephrine merchandise to toothpaste immunotherapy to deal with peanut allergy, and take part in a examine on birch allergy. Plus, try our mythbuster on whether or not it’s protected to get a flu shot it you’ve an egg allergy.


Take part: Assist us guarantee epinephrine auto-injectors proceed to be accessible with no prescription

auto-injectors

Well being Canada is asking Canadians via an open session about exemptions for prescription treatment. We’d like your assist to make sure epinephrine auto-injectors (e.g. EpiPen®, ALLERJECT®, EmeradeTM) proceed to be exempt on Well being Canada’s prescription drug checklist.

Having straightforward and immediate entry to epinephrine auto-injectors as a ‘behind the counter treatment’, that may be bought with no prescription, is important for each day administration and being assured that you’re ready to deal with a response if required. Plus, the exemption permits for others inside the neighborhood to entry and supply inventory epinephrine auto-injectors (units that aren’t prescribed to a particular particular person) for the emergency therapy of anaphylaxis – that is significantly necessary for surprising first time reactions.

Please full Well being Canada’s brief survey to make sure auto-injectors proceed to be accessible with no prescription by November 29, 2022. Fill out the survey with the next:

  • For Query A – choose “Cardiovascular and respiratory brokers” 
  • For Query 1 underneath “Cardiovascular and respiratory brokers” choose:
    • 1.5 Epinephrine autoinjectors
  • Fill within the open field textual content within the survey to elucidate why the inclusion of epinephrine auto-injectors is necessary to you. To make it simpler, you may copy and paste this paragraph:

Epinephrine auto-injectors are important for individuals residing with meals allergy and liable to anaphylaxis. Rapid entry to this treatment is required for individuals in danger and people who take care of them, particularly when surprising first time reactions happen. As such, a prescription ought to NOT be required for these life-saving units and they need to proceed to be on the exemption checklist.

We may also be offering a written submission to Well being Canada to request their continued help to maintain epinephrine auto-injectors on the exemption checklist.


Take part: Worldwide examine on meals allergy and airline journey

Traveler with mobile phone and passport

A worldwide analysis workforce led by US-based Northwestern College is conducting a examine to study extra about air journey experiences by individuals with meals allergy. Have your say by finishing the survey, and please share with others.


Analysis: Take part in a birch allergy examine

A birch allergy examine is underway at Cliantha Analysis in Mississauga, Ontario. They’re searching for wholesome adults to take part on this examine.

As there may be cross-reactivity with birch pollen and sure contemporary fruits, greens and tree nuts, some members within the meals allergy neighborhood who might also have a birch allergy is likely to be on this examine or know affected people who could possibly be .

Following is the announcement from the analysis workforce in your data and for sharing with people with birch allergy.

From the analysis workforce:

Enrolling members for a birch allergy examine

Medical trial at Cliantha Analysis

Cliantha Analysis in Mississauga, Ontario is enrolling members for a birch allergy examine. Our skilled analysis workforce, led by Dr. Patricia Couroux, is working carefully with pharmaceutical organizations to discover therapies for individuals with birch allergy symptoms.

What’s the objective of this examine?

The examine is researching examine medication referred to as REGN5713, REGN5714, and REGN5715 in several combos with one another to know whether or not extra antibodies, as in comparison with fewer antibodies or a single antibody, present larger enchancment in nostril and eye allergy signs resulting from birch pollen allergy in adults. The intention of the examine is to see how efficient the examine medication are at decreasing allergic nostril and eye signs. Allergic signs might be noticed in an Environmental Publicity Unit (EEU) (each throughout and never in the course of the birch pollen season) and in the course of the pure birch pollen season. Allergic nasal signs can embody congestion, runny nostril, and sneezing. Allergic eye signs can embody redness, itching, and swelling.

What are REGN5713-5714-5715, REGN5713-5715, and REGN5715?

REGN5713, REGN5714, and REGN5715 are investigational monoclonal antibodies. Antibodies are proteins produced by the physique to combat towards several types of illness. REGN5713, REGN5714, and REGN5715 are produced in a laboratory and bind to Guess v 1. Guess v 1 is part of birch pollen that makes most people who find themselves allergic to birch pollen have allergy signs. REGN5713-5714-5715 is a mix of all 3 antibodies and REGN5713-5715 is a mix of simply REGN5713 and REGN5715. Please word that this scientific trial will use an investigational drug product. The security and efficacy of which has not been absolutely evaluated by Regulatory Authorities, together with Well being Canada, and has no obtained advertising and marketing authorization in any nation.

Predominant eligibility standards for participation

  • Wholesome males and non-pregnant females
  • At the least 18 years of age at time of medical screening
  • Allergy to birch pollen
  • Extra standards might be assessed in the course of the phone pre-qualification evaluation and through medical screening

Research period

The examine period is roughly 46 weeks consisting of 13 clinic visits at Cliantha Analysis in Mississauga and two comply with up phone calls. There’s additionally an in-home part to reply questions on signs recorded in an digital diary that might be supplied to check members.

Compensation for participation

The compensation is $10,530 CAD for completion of the examine in its entirety. Contributors who qualify in Go to 1 and attend Go to 2, will obtain the V1 compensation quantity of $150 throughout Go to 2.  As soon as enrolled and as a result of size of the examine, members might be eligible to obtain compensation on a prorated foundation on the completion of Go to 4, Go to 8, Go to 10, and Go to 13. Last examine compensation for Go to 14, Go to 15, and the completion quantity might be paid inside 10 enterprise days of examine completion.

Easy methods to take part

Step 1: Cross a phone questionnaire to find out pre-qualification and registration (roughly a 20-minute name with a recruitment coordinator).

Step 2: Medical screening on the Cliantha Analysis clinic in Mississauga (roughly 5-6 hrs.). Throughout this go to, the next will happen:

  • You can be supplied with particulars of the examine together with any procedures, exams and/or every other points of the examine which is investigational.
  • It is possible for you to to assessment the knowledgeable consent type.
  • You’ll have the possibility to ask any questions you might have in regards to the examine.
  • Should you elect to signal the consent type, the examine physician or examine workers will carry out exams to find out for those who meet all the necessities to take part on this examine.

Participation and confidentiality

Participation within the examine is totally voluntary. You might refuse to take part, or chances are you’ll discontinue your participation at any time with out clarification. All data obtained throughout these research might be stored strictly confidential. The analysis information might be out there solely to the analysis workforce. This examine has been reviewed by Advarra IRB, an unbiased Analysis Ethics Board.

Registration

To register for the examine, contact us straight at (905) 282-1808 or click on on the next hyperlink, and a Cliantha workforce member will contact you inside 24 hours:

Registration Deadline: 26-Nov-2022

Questions

Please contact the Cliantha Recruitment Crew at (905) 282-1808 and we’d be completely satisfied to reply your questions and supply extra examine data. Our workplace hours are Monday to Friday 8:30am – 6:00pm and Saturday 8:30am – 4:30pm.

Cliantha Analysis Clinic

4500 Dixie Street

Mississauga, ON L4W 1V7

On-line examine data

Medical Trials.gov web site click on on this hyperlink:

Cliantha Analysis volunteer web site click on on this hyperlink:

Analysis: Needle-free epinephrine product developments

oral epinephrine film
Picture displaying sublingual therapy
Supply: aquestive.com

US-based Aquestive Therapeutics has introduced constructive written suggestions from the U.S. Meals and Drug Administration (FDA) on its AQST-109 product, a sublingual movie that may be utilized underneath the tongue for supply of epinephrine.

“We’re excited by the FDA’s written response confirming our strategy and supporting the characterization of our novel drug platform – an element that can accompany our NDA submitting for this product,” stated Daniel Barber, Chief Government Officer of Aquestive. “The constructive Company response reinforces our growth plans and strategy as we proceed to progress the AQST-109 program, together with in important areas comparable to assigning shelf life. We’re wanting ahead to our subsequent scheduled interplay with the FDA later this quarter the place we’ll talk about the outcomes of our EPIPHAST research and our scientific growth plan.”

Learn their press launch for extra data.

Needle-free epinephrine merchandise in growth for therapy of anaphylaxis embody each sublingual movie and nasal sprays; we’ll proceed to maintain you up to date with information.


Analysis: Toothpaste immunotherapy to deal with peanut allergy

Toothbrush with toothpaste

US-based Intrommune Therapeutics has introduced completion of section 1 enrollment in a scientific examine for sufferers with peanut allergy. On this examine, adults with peanut allergy could obtain an escalating dose of INT301. INT301 is an oral mucosal immunotherapy (OMIT); it comes within the type of a toothpaste to be integrated into an individual’s each day toothbrushing routine.

“Totally enrolling the OMEGA Medical Research is a big milestone for Intrommune as we proceed to progress our modern platform of merchandise to assist sufferers with meals allergy symptoms, together with peanut allergy,” stated Michael Nelson, CEO, Intrommune Therapeutics. “We’re inspired that, so far, sufferers enrolled in our OMEGA Medical Research have solely skilled delicate, transient adversarial occasions with no use of emergency epinephrine. Moreover, now we have each been capable of safely begin sufferers at dose 4 which can shorten the time to achieve upkeep remedy by a number of weeks, and efficiently dosed sufferers to a dosage larger than our anticipated upkeep dose.”

Learn their press launch for extra data.

It’s encouraging to listen to information of developments in allergy therapies and therapies, and we’ll proceed to share the knowledge with you.


Mythbuster – When you have an egg allergy, is it protected to get a flu shot?

Vials of influenza vaccine. ottles with a syringe on black table and stainless steel background.

With flu season upon us, learn our mythbuster to search out out whether or not it’s protected to get flu shot if in case you have an egg allergy.

Assist us educate your communities and share this mythbuster with them! Discover extra mythbusters at foodallergycanada.ca/mythbusters.



Tags: advocacy, name for participation, Epinephrine, mythbuster, Oral Allergy Syndrome, take part in analysis, Analysis