Additional Relevant Details Flamel Technologies today announced that it has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for the pivotal Phase III study of its once nightly Micropump based sodium oxybate product. The SPA will provide the FDA an opportunity to review and comment on the company’s planned study design, and once accepted, offers general acknowledgement by the FDA that the trial’s design, clinical endpoints and statistical analyses are acceptable and support the scientific and regulatory requirements associated with the product.