FDA Center for Veterinary Medicine Grants Innocan a Fee Waiver in 2026 for the Third Consecutive Time
Rhea-AI Summary
Innocan (OTCQB: INNPD) announced that the FDA Center for Veterinary Medicine granted a sponsor fee waiver for its LPT-CBD program for 2026, marking the third consecutive annual waiver. The waiver recognizes innovation for Innocan's liposomal CBD subcutaneous candidate for chronic pain in dogs.
In a randomized, blinded crossover study in osteoarthritic dogs, LPT-CBD showed a statistically significant reduction in pain versus placebo and improvements in overall well-being; company statements highlight a once-monthly subcutaneous dosing approach.
Positive
- Third consecutive CVM sponsor fee waiver for 2024–2026
- Statistically significant pain reduction in blinded crossover dog study
- Once-monthly subcutaneous dosing proposed for chronic canine pain
Negative
- CVM fee waiver is administrative and does not equal FDA approval
- Clinical evidence cited is limited to canine trials, not other species
AI-generated analysis. How Rhea-AI works. Not financial advice.
HERZLIYA,
The FDA's Center for Veterinary Medicine (CVM) assesses annual fees for animal drug applications. Sponsors developing innovative products may request a fee waiver each year under the "significant barrier to innovation" provision. Accordingly, every year Innocan submits an annual renewal request that includes a brief update on development progress and forward plans. Following review of the Company's latest submission, CVM has again granted Innocan a fee waiver for the year 2026. This represents the Company's third consecutive annual waiver, underscoring CVM's continued recognition of Innocan's innovation-driven animal health program.
The waiver relates to the Company's Liposomal Technology–CBD (LPT-CBD) drug product candidate, being developed as a subcutaneous injection for the management of chronic pain in dogs. In a blinded, crossover study conducted on osteoarthritic dogs, LPT-CBD demonstrated a statistically significant reduction in pain and meaningful improvements in overall well-being compared with placebo (empty liposomes) (1). Together with additional studies previously conducted in osteoarthritic dogs, these results provide robust evidence supporting LPT-CBD's analgesic potential and its suitability as a treatment option for chronic pain in dogs.
"The veterinary market is open to new drug technologies that can address the limitations of current pain medications and offer a new alternative therapy", Said Dr' Antonio Benitz, Innocan's animal health advisor. The fee waiver granted by CVM for the third time, recognizing LPT-CBD's innovation, reinforces Innocan's progress toward delivering a new solution for chronic pain in dogs.
Dr. Eyal Kalo, Vice President of Research and Development at Innocan added, "
Reference:
(1) Yael Shilo-Benjamini et al, Efficacy, pharmacokinetics and safety of liposomal synthetic cannabidiol injected subcutaneously in dogs: a randomized, blinded, placebo-controlled, crossover clinical trial, Front. Vet. Sci., 19 January 2026
About Innocan:
Innocan is an innovator in the pharmaceuticals and wellness sectors. In the pharmaceuticals sector, Innocan developed a CBD-loaded liposome drug delivery platform with exact dosing, prolonged and controlled release of synthetic CBD for non-opioid pain management. In the wellness sector, Innocan develops and markets a wide portfolio of high-performance self-care and beauty products to promote a healthier lifestyle. Under this segment Innocan carries on business through its
Contact Information:
For Innocan Pharma Corporation:
Iris Bincovich, CEO
+1 5162104025
+972-54-3012842
+442037699377
info@innocanpharma.com
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
Caution Regarding Forward-Looking Information
Certain information set forth in this news release, including, without limitation, the Company's plans for human trials of its LPT-CBD platform, is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond Innocan's control. The forward-looking information contained in this news release is based on certain key expectations and assumptions made by Innocan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of production and distribution arrangements.
Forward-looking information is subject to various risks and uncertainties that could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: global and local (national) economic, political, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and potential disruption of relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import/export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner). The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release. A comprehensive discussion of other risks that impact Innocan can be found in Innocan's public reports and filings which are available under Innocan's profile at www.sedarplus.ca.
Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. Innocan does not undertake to update, correct or revise any forward-looking information as a result of any new information, future events or otherwise, except as may be required by applicable law.
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SOURCE Innocan Pharma Corporation