InhaleRx fast-tracks development of inhaled cannabinoid-based formulations for panic disorder and CRPS

Medihale vape device creator InhaleRx (ASX: IRX) revealed development of its cannabinoid-based inhaled therapies has gathered momentum, with its panic disorder drug formulation showing “promising” preliminary stability results, and work on the complex regional pain syndrome (CRPS) drug underway.

Earlier this year, InhaleRx was granted licences from the Victorian Government to store and sell controlled substances, including medicinal cannabis.

The licences enable InhaleRx to wholesale scheduled substances, including Schedule 2, 3 and 4 medications, in addition to limited Schedule 8 substances, which includes medicinal cannabis.

Securing the licences was critical to InhaleRx’s strategy to develop inhaled cannabinoid formulations for conditions where there are no effective medical treatments.

The company aims to dispense the cannabinoid drugs via pressurised metered dose inhalers (pMDI) to provide rapid onset of relief.

Compared to oral and transdermal dispensing methods, inhaled treatments can quickly alleviate symptoms and are easy to use.

InhaleRx’s first two cannabinoid-based drug formulations under development are for panic disorder and CRPS. The company has assembled, what it describes as a “world class” team to drive the drug formulations to commercialisation in the “shortest time-frame possible”.

As part of this, InhaleRx has already shortlisted three contract manufacturers to supply the drug-pMDI combinations for upcoming clinical trials.

The company expects to make a decision on the manufacturer in the “coming weeks”.

Additionally, InhaleRx plans to issue tender documents “shortly” for contract research organisations.

Panic disorder formulation

In developing its treatment for panic disorder, InhaleRx is working closely with a UK-based formulation specialist.

The UK specialist is developing medication that can be dispensed via pMDI.

The initial formula has been developed, and stability testing is underway.

InhaleRx noted results from the one-month time point were “very encouraging”. Results from a three-month time point are due in early September.

The individual pMDI componentry has been determined and compatibility with the drug substance at the one-month stability time point “performed as expected”.

InhaleRx has preparations underway for a phase 2 (proof-of-concept) clinical trial with first patients expected to be enrolled between February and April next year.

On the regulatory side, InhaleRx is working with Premier Consulting to secure new drug approval from the United States Food and Drug Administration.

InhaleRx expects to have a pre-investigational new drug meeting with the FDA in the June half of 2023.

Panic disorder market

Existing drugs such as antidepressants, benzodiazepines, gabapentin and mirtazapine can reduce the frequency of attacks.

However, according to InhaleRx, there are no current therapies to satisfactorily manage sudden onset of symptoms.

In the US, about 6.97 million adults suffer from the disorder – equating to about 2.7% of the country’s entire adult population.

Medical costs for the condition are estimated at US$45.15 billion a year.

Complex regional pain syndrome (CRPS)

The other main drug formulation InhaleRx is creating is for treating CRPS.

The same UK specialist is developing the CRPS drug pMDI combination, with formulation activities kicking-off in June.

Since then, InhaleRx said “rapid progress” has been made with confirming the target dosage and solubility potential of the base formulation.

Results from a one-month stability time point are expected in early August, while selection of the pMDI device componentry has been shortlisted.

Preparations are underway for phase 1 and phase 2 trials, with first patient recruitment scheduled between June and August next year.

On the regulatory side, Premier Consulting has completed a detailed assessment and has prepared information to support a pre-investigational new drug meeting with the FDA.

Additionally, orphan drug designation has been filed with the FDA for the CRPS treatment. InhaleRx is now working through the next layer of data to support its application.

CRPS prevalence

InhaleRx noted that there are no existing drugs approved for specifically treating CRPS, with patients resorting to a combination of opioids/lyrica and atypical antidepressants.

The sudden onset of pain and time for these drugs to take effect is mismatched.

There are 219,317 confirmed cases of CRPS in the US, which cost the country about US$7.08 billion annually.

Medihale vape device

While advancing its panic disorder and CRPS treatments, InhaleRx has continued work on its Medihale vape device offering.

The company continues to offer industry white label opportunities but this commercial activity continues primarily for knowledge acquisition from doctors and patients about their experiences.

The company is in the process of trialling another vape devices to “better understand” the advantages and shortfalls.

There have been some fantastic insights provided by doctors regarding the role and need for medical devices with precision dosing. While the industry has witnessed a shift to adopt flower, there seems to be a cooling off with some medical professionals due to concerns with how flower is being inhaled and the associated dangers of combustion.