United Therapeutics has received complete response letter (CRL) from the FDA for an oral formulation of Remodulin (treprostinil).
Treprostinil is indicated for pulmonary arterial hypertension (PAH) that is at present available in subcutaneous, intravenous, and inhaled forms.
The FDA turned down the application and questioned the utility of oral Remodulin's efficacy.
The regulatory body mentioned the drug's inability to demonstrate an improvement in time to clinical worsening in three Phase III trials supporting the drug.
Drugs inability to demonstrate a statistically significant effect on 6 Minute Walk Distance in the FREEDOM-C studies was also cited.
FDA advised a fixed-dose design and frequent dosing should the company decide to undertake another trial.
