Full Press Release Details
To not have to get up in the middle of the night, EVERY SINGLE NIGHT." - A twice - nightly sodium oxybate patient Overall exposure (AUC) of FT218 meets bioequivalence criteria compared to AUC of twice - nightly sodium oxybate IR Overall Cmax of FT218 is lower than that of twice - nightly sodium oxybate IR Morning blood levels (C8h) of FT218 are similar to twice - nightly sodium oxybate IR 4.5 and 6g doses 8 CNS/SLEEP Avadel 2019.
Our primary focus is on the development and potential FDA approval for our Phase III orphan designated once - nightly sodium oxybate , FT218, for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy. In addition, we market three FDA approved sterile injectable drugs used in the hospital setting which were developed under our "unapproved marketed drug" (UMD) program.
S . Securities and Exchange Commission, including our annual report on Form 10 - K for the year ended December 31 , 2018 , and our quarterly reports on Form 10 - Q for the periods ended March 31 , 2019 and June 30 , 2019 , in particular disclosures that may be set forth under the captions "Forward - Looking Statements" and "Risk Factors," including without limitation : our dependence on a small number of products and customers for the majority of our revenues ; the possibility that our Bloxiverz , Vazculep and Akovaz products, which are not patent protected, could continue to face substantial and increased competition resulting in a further loss of market share and/or forcing us to further reduce the prices we charge for those products ; the possibility that we could fail to successfully complete the research and development for products we are evaluating for potential application to the FDA pursuant to our "unapproved - to - approved" strategy, or that competitors could complete the development of such products and apply for FDA approval of such products before us ; the possibility that our competitors may develop and market technologies or products that are more effective or safer than ours, or obtain regulatory approval and market such technologies or products before we do ; and our dependence on key personnel to execute our business plan .
These risks include : (a) risks relating to our recent cost - saving actions, including the risks that (i) such actions may not result in the amount of cost savings that we anticipate ; and (ii) such cost - saving actions may cause us to incur one - time costs in amounts greater than we anticipate ; (b) risks relating to the development of our investigational "FT 218 " sodium oxybate product, including the risks that (i) we may not have adequate capital to complete the development of FT 218 , we may need to obtain additional capital for such purpose, and such additional capital may not be available on attractive terms or at all ; (ii) we may be unsuccessful in accelerating the pace of our clinical trial enrollment for the Phase 3 REST - ON clinical trial, or we could experience delay or failure in completing that clinical trial ; iii) we may encounter challenges in the remaining development efforts for FT 218 ; iv) the FDA may determine there are deficiencies in the NDA for FT 218 or may never approve the NDA for FT 218 ; v) FT 218 may not have the therapeutic benefits we anticipate ; vi) the commercial launch of FT 218 could be delayed ; vii) FT 218 may not achieve commercial acceptance ; and viii) other companies may develop competing products that may receive FDA approval before FT 218 ; and (c) the other risks, uncertainties and contingencies described in the Company's filings with the U .
The words "will," "may," "believe," "expect," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof, identify forward - looking statements, each of which speaks only as of the date the statement is made . Although we believe that our forward - looking statements are based on reasonable assumptions within the bounds of our knowledge of our business and operations, our business is subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and our results of operations will not differ materially from the results contemplated in such forward - looking statements .