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The Journey of Sublingual Immunotherapy to Regulatory Acceptance

Allergies have been a common problem across the world. Sublingual Immunotherapy (SLIT) is one of the possible solutions that can be helpful for every allergy sufferer. Now, one question might come to one’s mind: what is stopping the FDA from approving sublingual immunotherapy (SLIT) for allergies?

SLIT is an allergic treatment in which a small amount of allergen extract is put under the tongue. Companies like Curex offer allergy drops for indoor as well as outdoor allergies. This treatment is supposed to desensitize the immune system of the patient to any form of allergy a patient might be experiencing. Unlike the conventional allergy shots that involve needles, SLIT is done painlessly.

The FDA regulates products that impact public health by ensuring the safety and effectiveness of such products. Its very onerous regulatory process has been a hindrance to FDA approval for SLIT. The main hitch in the way of FDA approval for sublingual allergy immunotherapy is the need for a standardized dose. Allergy drops are customized depending on the sensitivity level of a person, and so dosage levels for the drops vary. This customization of the dose makes it difficult for the drug to be approved because a standard dose must be given for approval.

Though this form of immunotherapy is not approved by the FDA, most of the patients undergoing sublingual immunotherapy have had a decrease in their allergic symptoms. Clinical studies have shown a drastic reduction in the severity of symptoms of allergic rhinitis with SLIT. The benefits of SLIT, such as the lessening of symptoms, might be long-lasting even after cessation of the therapy.

Efforts to consider other means of future approval are in motion while the FDA approves the process. The FDA has developed routes for approval of personalized medicine with the use of biomarkers and surrogate endpoints to define treatment effectiveness. Those routes offer opportunities for robust clinical trials to demonstrate the safety and efficacy of SLIT. In addition, many of the ingredients in the allergy drop formulations are FDA-approved, which suggests that these formulations may not need de novo approval. 

It is important that anyone considering allergy drops consult with a healthcare provider. The providers will be able to assess the appropriateness of SLIT for particular allergies and assist patients in ensuring that they receive safe administration and a good source of extracts. The road from allergy drops to FDA approval may be arduous, but the promising benefits of allergy treatment shouldn’t be ignored. Work in the field of personalized medicine will continue, and one day, the proper regulatory recognition of allergy drops will be given.