InhaleRx reveals ‘important progress’ in inhaled cannabinoid drugs for CRPS and panic disorder

Australian biotech InhaleRx (ASX: IRX) has made “important progress” in the development of its novel inhaled drug formulations for complex regional pain syndrome (CRPS) and panic disorder.

CRPS is described as a chronic pain syndrome with paroxysmal breakthrough pain, which needs immediate pain relief to manage.

Similarly, panic disorder, which causes sudden overwhelming anxiety symptoms requires instant onset anxiolysis to resolve unexpected episodes.

Clinical trials

InhaleRx is gearing-up to begin clinical trials this year of its synthetic cannabinoid-based drugs, which have been designed to be delivered via inhalation for treating these conditions.

Over the past year, InhaleRx has developed the formulations for CRPS and panic disorder and completed stability testing.

Other activities include drafting of clinical trial protocols and investigator brochures; procuring the necessary active pharmaceutical ingredients, and pressurised metred dose inhale (pMDI) device components; commissioning manufacturing of the trial drugs; and completion of an international tender for selection of a clinical research organisation Ingenu CRO to oversee the trials.

Contract research organisation

InhaleRx chairman Sean Williams noted Ingenu had been selected via a comprehensive tender process.

“Ingenu was selected on the basis of its capability and experience as a specialist cannabinoid CRO, which enabled it to develop and present an attractive tailored, time efficient and cost-effective approach to IRX’s clinical trial requirements.”

At the company’s extraordinary general meeting earlier this month, shareholders approved Ingenu CRO to oversee the CRPS and panic disorder clinical trials.

The Ingenu appointment required shareholder approval because it is considered a related party. It is a subsidiary of InhaleRx’s substantial shareholder Cannvalate.

“We look forward to working closely with Ingenu over the next 12-18 months as we complete our planned phase 1 and 2 clinical trials for CRPS and phase 2 panic disorder clinical trials,” Mr Williams said.

He noted the planned clinical trials are among the first ever to be undertaken involving inhaled cannabinoid medications for treating pain and anxiety-related conditions.

“Furthermore, we expect that they will also be the first clinical trials for inhaled cannabinoid treatments for CRPS and panic disorder to be completed anywhere in the world.”

“The IRX board and management team are very excited about the prospect of getting the clinical trial programs underway and are very optimistic about where these program may lead.”

Inhaled medications

InhaleRx’s overarching goal is to achieve new drug approvals with the United States Food and Drug Administration for its first two inhaled cannabinoid therapeutics and any others it may develop.

Unlike oral, transdermal or injectable delivery methods, inhalation of medicines provides fast-onset, while remaining minimally invasive and retaining high bioavailability.

As such it provides patients “ease of use” and provides fast and simple management of acute episodes such breakthrough pain and anxiety.