This epinephrine sublingual spray is designed for emergency situations.
The FDA’s feedback could potentially lead the company to a New Drug Application (NDA) submission.
The FDA-approved epinephrine prodrug used in IN-001 enhances both stability and absorption, offering a needle-free alternative for anaphylaxis treatment.
This positive feedback follows a Phase I study that showed IN-001 achieved comparable epinephrine pharmacokinetic (PK) profiles to injections, with the added convenience of needle-free administration. The company is not required to conduct placebo-controlled efficacy studies.
IN-001’s proposed PK/pharmacodynamic (PD) trials in healthy individuals could pave the way for FDA approval.
If successful, IN-001 could be used to treat critical allergic reactions, including anaphylaxis of unknown causes and exercise-induced anaphylaxis.
In July 2024, the FDA granted IN-001 fast track designation, expediting the review process and supporting the company’s aim to quickly bring this therapy to market.
The recent positive results for IN-001 in Phase I study A24-1889, highlighted its effectiveness and ease of use, suggesting it could replace needle-based treatments.
The study involved six healthy adults and demonstrated that IN-001 rapidly achieved the FDA’s required plasma epinephrine concentration threshold of 100 pg/mL.
Anaphylaxis is a serious, rapid allergic reaction that can be life-threatening and leads to swelling, hives, and difficulty breathing.
Insignis Therapeutics CEO Mingbao Zhang said: “This favourable FDA feedback is a significant milestone in our journey to transform anaphylaxis treatment.
”IN-001 offers a potentially life-saving, user-friendly alternative to injectable epinephrine, helping reduce the fear and complexity associated with traditional autoinjectors. We are excited to continue working with the FDA to bring this groundbreaking product to market.”