FDA is open to give the SPA the green light

It was recently announced that Advanced Life Sciences has reached an agreement with the US Food and Drug Administration (FDA) over the design of its planned Phase 3 study of Restanza for the treatment of community acquired bacterial pneumonia (CABP). Given the green light through the special protocol assessment (SPA) process, the trial is now the first prospectively designed superiority study to be conducted into the condition.

According to Advanced Life Sciences, the double-blind pivotal superiority study will consider the efficacy and safety of 300mg of Restanza over a week of treatment to azithromycin. The primary endpoint will be to see the clinical cure rate in a macrolide-resistant streptococcus pneumoniae (MRSP) population.

However, the unique features are arguably the most notable aspect. Among those is the inclusion of patient-reported outcome measures, which have been introduced with a view to producing more robust evidence of the drug’s effectiveness and its ability to treat pneumonia. This has taken on major importance for Advanced Life Sciences, as the firm looks to showcase that Restanza could be used by patients with a resistance to marketed macrolide antibiotic drugs.

Dr Michael T Flavin, chief executive of Advanced Life Sciences, said the firm was pleased that the FDA was open to giving the SPA the green light.

“We believe that the superiority-based SPA represents a precedent-setting clinical trial design for oral antibiotics and will make a significant contribution to the field of CABP and antimicrobial clinical trial design,” he explained.

All the above aspects of innovation in clinical design will be covered at Pharma IQ conference, Innovation in Clinical Design, Analysis and Reporting. The event takes place in London, 07th-08th December 2010. Laurence Colin from Novartis will present ‘Design of a proof-of-concept study in diabetic nephropathy using historical placebo data’ case study. Chrissie Fletcher, Biostatistics Director from Amgen will be discussing strategies to maximise reimbursement success in clinical design and Jose Pinheiro, senior director from Johnson and Johnson will be evaluating adaptive designs for practical use in clinical development.

If you want to know more about the event, please visit www.clinicalreporting.co.uk