SEATTLE– Receptor Life Sciences (RLS) today announced the completion of a pre-investigational new drug (preIND) meeting with the U.S. Food and Drug Administration (FDA). The meeting resulted in clear guidance on the regulatory requirements for the development and approval of RLS103 under section 505(b)(2). RLS103 is an investigational inhaled cannabidiol (CBD) designed for the treatment of acute panic attack.
“Alignment on a clear 505(b)(2) development pathway for RLS103 is a significant milestone for the company,” said Andrea Leone-Bay, PhD, Chief Scientific Officer of RLS. “Currently no immediate-acting products are available for panic attacks, so RLS103 has the potential to be First-in-Class. We look forward to continuing our dialogue with the FDA and have initiated our IND-enabling studies.”
Panic disorder affects approximately 5.4 million adults (2.7% of the population) in the U.S., according to the National Institute of Mental Health. Benzodiazepines are the most common treatment for panic despite their well-known undesirable side effects, including dependence, sedation, and tolerance. An inhaled CBD formulation holds the potential to treat panic in a safe, effective, and convenient manner.
RLS103 is a drug-device combination product based on the Technosphere® dry powder inhalation system licensed from MannKind Corporation.
The FDA’s 505(b)(2) pathway was established in 1984 to accelerate the development of promising new medications by allowing the use of data based on previously approved drugs. (IANS)
