RE:Patent Allowance Granted for ALA-002 Composition C.MDMA"The Company believes that this is an Orphan Indication, in that there are no FDA-approved treatments currently available for social anxiety in autistic patients. However, the Company also believes that ALA-002 could be useful in the treatment of a number of neurological and neuropsychiatric disorders."
Here is information on FDA Orphan Designation Below: Supporting the development and evaluation of new treatments for rare diseases is a key priority for the FDA. The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. Orphan drug designation qualifies sponsors for incentives including:
- Tax credits for qualified clinical trials
- Exemption from user fees
- Potential seven years of market exclusivity after approval
Sponsors seeking orphan drug designation for a drug must submit a request for designation to the agency. Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information to support their designation request. Orphan drug designation is a separate process from seeking approval or licensing. Drugs for rare diseases go through the same rigorous scientific review process as any other drug for approval or licensing.
See the orphan drug designations and approvals database for more information.
How to submit orphan drug designation requests
Sponsors may submit orphan drug designation requests one of three ways:
- Through the CDER NextGen portal
- By emailing the required information to orphan@fda.hhs.gov
- By mailing the required information to:
Office of Orphan Products Development
Attention: Orphan Drug Designation Program
Food and Drug Administration
WO32-5295
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002