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Cytogel Pharma Announces Receipt of FDA Authorization to Commence Phase 2  Development for its Atypical Opioid, CYT-1010

DARIEN, Conn., Feb. 5, 2019 /PRNewswire/ -- Cytogel Pharma, LLC. today announced receipt of the official response from the U.S. Food and Drug Administration (FDA) regarding the Company's amendment to the Complete Response Letter (CRL) for the CYT-1010 Investigational New Drug (IND) application.

FDA has agreed that the Company may proceed with its phase 1a/2a study protocol titled,  A Randomized Double-Blind, Single-Dose, Placebo-Controlled Pharmacokinetic and Proof-of-Concept Study to Evaluate the Safety of CYT-1010 in Healthy Volunteers and the Analgesic Efficacy and Tolerability of CYT-1010 vs. Morphine in Subjects with Moderate to Severe Pain after Third Molar Extraction.

The FDA issued authorization that allows this study to proceed.  This will be an important proof of concept study and dose ranging study to demonstrate the effectiveness and safety of CYT-1010 in both volunteers and patients with significant pain.  The FDA indicated that, upon completion of the above study, the Company should submit data to the Division for advancing to higher doses of CYT-1010, hence a partial clinical hold (PCH) in development will be in effect.  The Division will review these data before lifting the PCH and allowing higher doses of CYT-1010. 

"We are pleased with the productive dialogue with the FDA and their decision to authorize the initiation of phase 2 development of CYT-1010 by approving this first study protocol, opening a pathway to full clinical development of CYT-1010.  This is an important step forward for the Company.  We believe the design of the phase 1a/2a study will allow for demonstration of safety and efficacy of this novel candidate in the treatment of post-operative pain," said C. Dean Maglaris, President and Chief Executive Officer.  "Our mission is to address the needs of post-operative pain treatment, by providing effective analgesia that would not be as limited by the serious side effects of the classical opioids, namely respiratory depression and addiction.  This is our objective for CYT-1010, based on its mechanism of action that is novel among opioids."

The Company also announced that it is currently completing a bridge financing, which will shortly lead to a follow-on round of financing to fund its development programs.  If completed, management expects these financings should be sufficient to fund operating expenses and project expenditure requirements into first quarter 2022. 

About Cytogel Pharma 
Cytogel Pharma is a biopharmaceutical company focused on developing promising early-stage, novel products for the treatment of moderate to severe pain, that could avoid the classical serious side effects of existing opioids and other analgesics.  The Company has identified and protected a number of product candidates that hold promise for success in this arena.  Its lead product candidate is CYT-1010, an endomorphin 1 analog, an atypical opioid with a demonstrated novel mechanism of action that in pre-clinical studies and one early clinical study, has shown fewer of the serious side effects of the classical opioids.  It is currently being developed for use in treating post-operative pain, by IV administration.  The Company's portfolio also includes broadly useful polymer and hydrogel drug delivery technologies, which can be useful in enhancing the pharmacokinetics of other drugs.  

Disclosure Notice
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals.  This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration.  Any potential benefits that may be implied by these statements involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may not share our views on the safety and/or effectiveness of a product candidate and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any new drug applications for CYT-1010 may be filed with regulatory authorities in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be filed or pending for CYT-1010, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CYT-1010.

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Last Updated: 06-Feb-2019