The US Food and Drug Administration have finally accepted Advancis Pharmaceutical's new drug application (NDA) for its once daily amoxicillin Pulsys product for tonsillitis and pharyngitis.
After a series of exchanges following the initial rejection of the company's NDA back in February, Advancis yesterday announced that the FDA have accepted the resubmitted filing, and all should be on for a PDUFA (Prescription Drug User Fee Act) target action date of January 23 next year.
If the amoxicillin formulation submitted to the FDA is eventually approved, it will be the market's first once-daily product in the aminopenicillin class for the treatment of pharyngitis, and use only half of the amoxicillin used in current treatments.
This would conceivably have a positive impact on patient compliance (of key importance with antibiotic treatments), as it would provide an alternative to the thrice daily 500mg dose that must be continued for 10 days under current treatment regimens.
The new formulation is based on Advancis' Pulsys technology, which the company developed specifically to target infectious diseases. The technology centres around the discovery that bacteria exposed to antibiotics in short, repetitive bursts or pulses are killed more efficiently than with multiple dosing regimens, and do not tend to develop more resistant forms.
The drug dosage form itself takes the form of a compressed tablet which contain pellets that release the drug in a controlled manner a different regions throughout the gastro-intestinal tract in the short pulses described above.
The dosage form is made up of a variety of pellet types with a range of release profiles that are put together in such a combination as to produce a constant escalation in plasma drug levels in the initial dosing period. According to the company, the pellets enhance the absorption-time window as well as offering improved bioavailability compared to tablet matrix forms.
All the Pulsys products developed by the company are intended as once-daily products, and use well-known excipients and common manufacturing processes.
The company originally submitted an NDA for the once-daily amoxicillin Pulsys product for the treatment of adult and adolescents with acute pharyngitis and/or tonsillitis back in December last year.
The FDA's 'refusal to file' letter came through in February, requesting more information from Advancis regarding its planned commercial manufacturing processes before the submission could be accepted.
After meeting with the agency and resubmitting the revised NDA in March this year, the positive response announced this week means that the company still hopes to be able to commercially launch the product to healthcare professionals by the beginning of the 2008/9 cough and cold season.
The company has been forced to initiate cost reductions and postpone certain clinical development programs in an effort to minimize outgoings, but has clung on to the amoxicillin Pulsys product plans.
At present, Advancis plans to use third party manufacturers for the new product, and has forecast spending $7m-$8m during 2007 to complete the build-out of the contract manufacturer's facility in Clonmel, Ireland, and a further $1m to kit the plant out with suitable equipment.
However, despite the promising news from the FDA this week, the company's comments released with its full year results make for more somber reading as the firm's financial situation takes its toll on development plans, with the company warning that future development of Pulsys products (and business operations as a whole) rely entirely on whether Advancis will be able to secure sufficient additional funds.