Emyria targets US drug approval with new high-dose synthetic CBD capsule

The Cannabis Observer ·
Emyria targets US drug approval with new high-dose synthetic CBD capsule

Emyria has produced a high-potency synthetic CBD capsule and is pursuing registration of the drug in the United States.

The product, EMD-RX9, delivers 150mg of CBD per capsule — three times the dose of its Australian over-the-counter candidate, EMD-RX5.

Emyria plans to run a phase 1 head-to-head pharmacokinetic (PK) study against Epidyolex later this year, with the findings intended to support pre-IND meetings with the US Food and Drug Administration (FDA).

Earlier animal studies showed a separate product, EMD-RX7, had four times the bioavailability of Epidyolex.

Chief executive Dr Michael Winlo said: "The higher dose strength and potency of EMD-RX9 will support Emyria's US-focused registration programs by helping the needs of patients requiring high-CBD doses.

"We are confident EMD-RX9 will demonstrate superior bioavailability compared to Epidyolex oil based on earlier head-to-head preclinical PK studies performed with EMD-RX7 and, together with our real-world data insights, can help Emyria's growing ultra-pure cannabinoid product pipeline address the unmet needs of large patient populations."

The therapy is aimed at new and existing prescription indications where patients require higher CBD doses.

The Perth-based biotech said the capsule format would appeal to patients who prefer the "convenience and tolerability" of a solid capsule over an oil-based product.

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