Does Curex Have FDA Approval?
The FDA has approved specific single-allergy immunotherapy tablets for sublingual administration. Learn more about what treatments with Curex are FDA-approved.
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What is FDA approval?
FDA approval is a certification by the U.S. Food and Drug Administration (FDA) indicating that a drug, medical device, or food additive has been rigorously tested for safety and efficacy and found to meet strict standards. This approval ensures that consumers and healthcare professionals can trust the quality and reliability of medical treatments and products and that the benefits outweigh the known and potential risks.
To gain FDA approval, a product must go through several stages of testing, including laboratory and animal testing, followed by clinical trials in humans. These trials are designed to assess the safety and efficacy of the product. After successful trials, the manufacturer submits a detailed application to the FDA for review. The FDA then thoroughly evaluates the data to decide if the product can be approved for public use. On average, it takes ten years and hundreds of millions of dollars to get a new medication approved by the FDA. Only about ten percent of potential drugs make it through the rigorous process to become FDA approved.
Not all allergens or formulations have FDA approval
Allergy immunotherapy can be administered subcutaneously through allergy shot injections or sublingually through allergy tablets or allergy drops. All forms of immunotherapy consist of a combination of allergenic extracts, which are FDA approved biological medications.
The allergenic extracts have been approved for injections for many decades. Because allergy shots have been in use by the medical community for over 100 years, they are considered safe and effective. With this long history, the extracts were “grandfathered” by the FDA as approved medications for use in allergy shots.
In the early 2000s, the manufacturers of allergenic extracts made significant investments in clinical studies, estimated to cost over $1 billion. These studies focused on use of allergenic extracts in sublingual allergy immunotherapy, specifically sublingual tablets, targeting one allergy at a time. In 2014, one such sublingual tablet received approval and soon others followed. Currently these are sublingual allergy immunotherapy tablets with the FDA approval:
Odactra: approved for sublingual treatment of house dust mite allergies.
Ragwitek: approved for sublingual treatment of ragweed pollen allergies.
Grastek: approved for sublingual treatment of certain grass pollen allergies.
Oralair: approved for sublingual treatment of a specific mix of five grass pollens, including Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky BlueGrass.
The FDA approval for these medications was a huge win for patients. Indeed, sublingual allergy immunotherapy can be taken at home and generally is more affordable than allergy shots.
However, the tablets also have certain disadvantages. They cannot be personalized, especially for people who have more than one allergy. The majority of allergy sufferers, unfortunately, prefer to undergo immunotherapy for the entire mix of allergies. With such growing patient demand, doctors frequently recommend and prescribe personalized allergy drops, which consist of the same biologic extracts.
However because some extracts have never been approved for sublingual use, such prescriptions are considered off-label. The manufacturers of extracts are prohibited from marketing them for such use. But doctors can prescribe them, if there is medical necessity. A recent survey of U.S. allergists suggested that 73.5% of allergists have prescribed allergy drops for their patients, and generally personalized drops are considered safe and effective (though not yet approved by the FDA). Overall, as many as 50% of prescriptions in the U.S. may be off-label.
An additional benefit of allergy drops prescribed off-label is that they can save patients as much as $500/month when compared to tablets or allergy shots.
While these treatments can be very effective for many individuals, they might not be suitable for everyone, and their use should be based on a careful assessment of each patient's medical history and allergy profile.
Curex's approach involves customizing treatment based on individual patient profiles and test results prescribing a mix of different allergens. This personalized approach aims to prescribe a tailored mix of different allergens, potentially addressing a broader range of allergens than those covered by FDA-approved formulations.
Such customized treatments could offer several advantages. First, they can be specifically tailored to the unique allergy profile of each patient, potentially improving effectiveness and patient satisfaction. Second, they could address a wider range of allergens, including those not covered by FDA-approved treatments, thus benefiting a larger segment of allergy sufferers.
However, conducting double-blind clinical studies on allergy drops or allergy shots targeting multiple allergies proves challenging due to the inherent variability among patients' allergy profiles. Take Sam and Kate, for example; their sets of allergies could significantly differ, requiring distinct treatment mixes. Introducing this variability into clinical studies would complicate data interpretation.
As a result, no clinical studies have yet been conducted on allergy drops or allergy shots for multiple allergies. In the US, allergy immunotherapy typically involves treating patients for multiple allergies, requiring doctors to rely on their expertise and established guidelines when prescribing treatments.
How to Know if a Product has FDA approval
To determine whether a product has received FDA approval, there are several steps you can take:
Check the FDA Website:
The FDA maintains an extensive database of approved products on their official website. You can search for specific drugs, biologic products, and medical devices. For drugs, the Drugs@FDA database is a useful resource.
Look for the FDA Approval Label:
FDA-approved products typically include labeling that indicates their approval status. This label can be found on the product's packaging or in the prescribing information.
Consult a Healthcare Provider:
Healthcare professionals have access to resources and databases that can confirm whether a product is FDA-approved. They can provide reliable information on the approval status and appropriate use of a product.
While the FDA has not yet reviewed clinical studies for drops or shots with multiple allergies, allergy shots have been "grandfathered in" due to their widespread use since the 1920s and their well-established safety and efficacy. On the other hand, allergy drops, introduced in the 1990s and despite being administered to millions of patients worldwide, remain unapproved by the FDA. This means that when doctors prescribe allergy drops, they do so off-label. While this practice is legal and common, pharmaceutical companies are restricted in marketing their allergenic extracts for use in allergy drops due to the lack of FDA approval.
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