FDA Approval of Ryanodex® Marks Milestone for Lyotropic Therapeutics

Lyotropic Therapeutics’ lead pipeline product, Ryanodex® (dantrolene sodium), has been approved by the FDA for the treatment of Malignant Hyperthermia. Eagle Pharmaceuticals, Lyotropic Therapeutics’ exclusive licensee for the product has received FDA approval of its New Drug Application for Ryanodex and will begin taking orders for the product this month.

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Benjamin Cameransi, M.D.

FDA approval of Ryanodex marks the availability of a major advance in the clinician’s ability to quickly prepare and deliver dantrolene sodium in the face of a fulminating MH crisis.

Richmond, Virginia (PRWEB) August 06, 2014

Lyotropic Therapeutics (Ashland, Virginia) today announced that its license partner, Eagle Pharmaceuticals, has received marketing approval by the U.S. Food and Drug Administration (FDA) for RYANODEX® (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. Ryanodex was developed and patented by Lyotropic Therapeutics and is licensed exclusively to Eagle Pharmaceuticals.

About Malignant Hyperthermia
MH is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. Once triggered, a rapidly progressing reaction involving sustained muscle contraction occurs with catastrophic consequences. Essential to the successful treatment of MH is the rapid institution of dantrolene sodium therapy and control of associated symptoms. Until now, dantrolene sodium preparation entailed a time-consuming reconstitution process and required several people for its preparation, a process that can take 15 to 20 minutes to mix, reconstitute and administer. Lyotropic Therapeutics developed Ryanodex to save critical time in preparation and administration of dantrolene sodium. Ryanodex can be prepared and administered in less than one minute by a single healthcare practitioner.

"Rapid administration of dantrolene sodium has long been recognized as key to reversal of MH. FDA approval of Ryanodex marks the availability of a major advance in the clinician’s ability to quickly prepare and deliver dantrolene sodium in the face of a fulminating MH crisis,” said Benjamin Cameransi, Jr., M.D., D.A.B.A., Vice President of Medical Affairs at Lyotropic Therapeutics. “In addition, approval of Ryanodex strongly validates the Company’s strategy of developing clinically significant new drugs backed with sound proof-of-concept data and then seeking a partner well positioned to complete product development and market the product.”

About Lyotropic Therapeutics
Lyotropic Therapeutics, Inc., based in Ashland, Virginia, is a pharmaceutical development company applying its substantial base of drug delivery technologies to develop unique, proprietary products with the goal of offering major therapeutic advances in patient safety and efficacy. The Company’s approach to product development and partnering has resulted in a significant portfolio of development stage injectable products in the field of anesthesia, pain management and critical care.

CONTACT:

for Lyotropic Therapeutics, Inc.

Vince Conklin, CEO
804.412.1030
vconklin(at)lyotropics(dot)com

Benjamin Cameransi, M.D. , D.A.B.A.,
Vice President of Medical Affairs
912.321.9112
bcameransi(at)lyotropics(dot)com
SOURCE Lyotropic Therapeutics, Inc.


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  • Vince Conklin
    Lyotropic Therapeutics, Inc.
    8045501280
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