PharmaTher Submits FDA Meeting Package to Discuss 505(b)(2) Pathway for New Drug Application of KETARX™ (Ketamine) On-Body Pump System
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has submitted its Type B meeting package to the FDA to discuss requirements for the KETARX™ On-Body Pump System. The meeting is scheduled for March 23, 2023. PharmaTher aims to submit a New Drug Application (NDA) by the end of 2023, using its clinical and non-clinical data. The company intends to seek FDA approval for the device to enhance general anesthesia and sedation procedures. The KETARX™ system may provide improved administration of ketamine while potentially extending its use in mental health and pain disorders. However, no assurance of expedited approval is provided.
- PharmaTher has scheduled a meeting with the FDA to discuss KETARX™ requirements, indicating progress in the approval process.
- The company aims to submit an NDA by the end of 2023, which could expedite market entry.
- KETARX™ is positioned to enhance ketamine administration, potentially benefiting multiple medical fields.
- There is no guarantee that the FDA will approve the expedited path for the KETARX™ system.
- The reliance on FDA approval poses significant risks for market entry and potential revenue generation.
TORONTO, Feb. 07, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in advancing specialty ketamine pharmaceuticals, today submitted its Type B meeting package with the U.S. Food and Drug Administration (“FDA”) to discuss the remaining requirements for the KETARX™ On-Body Pump System (subcutaneous racemic ketamine) and submission of a New Drug Application (“NDA”) under the 505(b)(2) pathway. PharmaTher aims to leverage its own CMC information, clinical data and available non-clinical and clinical data to submit an NDA by the end of 2023. The meeting date with the FDA is set for March 23, 2023.
Fabio Chianelli, CEO of PharmaTher, commented: “We are in a position to meet with the FDA to obtain guidance on the final requirements for our KETARX™ On-Body Pump System to support a new drug application under the 505(b)(2) pathway. In the short term, we will seek FDA approval for our KETARX™ On-Body Pump System in general anesthesia and sedation for surgical procedures. If successful, this strategy would create a strong foundation in efficiently expanding to mental health, neurological and pain disorders.”
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a00a7676-5b59-44a6-835a-f3ea3464bfb2
PharmaTher aims to obtain FDA approval for the KETARX™ On-Body Pump System for the maintenance of anesthesia and as a supplement to other anesthetic agents in alignment with ketamine’s FDA-approved label. In addition, the use of the KETARX™ On-Body Pump System for sedation during short-term diagnostic and surgical procedures is also being explored to extend the label for specific areas of application or types of procedures where the subcutaneous route of administration would be viable. This approach supports and potentially improves the administration of ketamine in both hospital and clinical settings.
The Company believes that subcutaneous infusion of racemic ketamine via the KETARX™ On-Body Pump System has several advantages over commonly used intravenous (“IV”) administration, including decreased requirement for skilled personnel for its administration, reduction in pain and irritation associated with administration, and a reduced risk of systemic infection and other complications seen with IV administration. Subsequently, should the KETARX™ On-Body Pump System obtain FDA approval, it will allow the Company to leverage its regulatory package and clinical data to expand to mental health (i.e. depression, PTSD), neurological (i.e. Parkinson’s disease) and pain disorders. This is further supported by the KETARX™ On-Body Pump System’s capability to provide either anesthetic or subanesthetic dosing over a defined time period.
Ketamine was approved by the FDA in 1970 and is indicated:
- as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation;
- for the induction of anesthesia prior to the administration of other general anesthetic agents; and
- as a supplement to other anesthetic agents (for the indication of IV or IM induction of anesthesia and maintenance of anesthesia.
Currently, ketamine is emerging as a viable treatment option for depression. In addition, there is a growing off-label use of racemic ketamine for various mental health conditions and pain, requiring IV administration and supervision by healthcare providers in hospitals or certified medical clinics.
There can be no assurance that the FDA will support any potential request for an expedited path to approval or further development for KETARX™ On-Body Pump System.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty pharmaceutical company focused on developing and commercializing KETARX™ (racemic ketamine) via unique delivery methods for mental health, neurological and pain disorders. Learn more at PharmaTher.com.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
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This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim", “may” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the three and six months ended November 30, 2022 ("MD&A"), dated January 23, 2023, which is available on the Company's profile at www.sedar.com.
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FAQ
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