InhaleRx Ltd (IRX) is an Australian biotechnology company focused on the development of precision medicine delivered via inhalation.
Leaders in the development of innovative inhaled therapeutics to address unmet medical needs for the benefit of the global health care market.
Targeting acute symptoms that patients experience in two therapeutic areas, Mental Health, and Pain, the company is pursuing New Drug Approvals (NDA’s) with the Food & Drug Administration (FDA).
World-first rapid onset treatments for carefully chosen acute conditions with a large total addressable market.
There are many treatment options available to patients that suffer from chronic conditions, but there’s very few safe and effective options that target acute episodes.
Acute treatment options can be used as an adjunct to chronic therapies, or in some cases may replace the need for use of medications to manage symptoms.
The pain management market is estimated to be worth $75 billion (USD) in 2023, with a CAGR 3.6% between 2023 and 2028*.
The global anxiety disorder treatment market is projected to reach USD 9 billion by 2030 at 2.9% CAGR during the forecast period 2022-2030. It includes panic disorders, post-traumatic stress disorder (PTSD), phobias, and obsessive-compulsive disorder.
GLOBAL ANXIETY DISORDER TREATMENT MARKET
Time to approval – only 3 to 4.5 years (compared to the usual 10+ years)
Enabling access to use data from previously conducted studies of approved drugs can result in a faster approval process as the FDA.
There are often significant cost-saving opportunities as companies can leverage previously conducted studies of approved drugs, which can reduce the costs associated without executing a full drug-development program.
The FDA may not require a full complement of preclinical and clinical studies.
The 505(b)(2) pathway provides opportunities to incrementally innovate on already approved drugs.