The low dose version of PA32540 is called PA8140. PA8140 is not listed in their pipeline or on their website -- from company's latest 10Q:
The FDA indicated that it will make a final determination during the NDA review. Based on these discussions with the FDA, the Company does not plan to conduct any further bio equivalence studies with PA32540. The FDA also indicated that a similar strategy to bridge to the reference listed drug, inclusive of a new, single pharmacokinetic study, could be utilized for a low dose version of PA32540 (currently, PA8140). The Company is conducting this study with the low dose version against the EC aspirin 81 mg, and plans to submit these results and other supporting data in the NDA.
During a pre-submission meeting with respect to its NDA for PA32540 in April 2012, the FDA suggested that the Company also seek approval for a lower dose formulation of the product containing 81 mg of enteric coated aspirin as part of its NDA for PA32540. Absent the availability of such a lower dose formulation in the market if PA32540 is approved, the FDA indicated that it may limit the indication for PA32540 to use in post coronary artery bypass graft surgery (CABG) with treatment duration not to exceed one year. The Company believes that the FDA is concerned that without a formulation containing a lower dose of aspirin, physicians will not have a full range of dosing options available to prescribe in accordance with current cardiovascular treatment guidelines, which recommend doses of 81 mgs or 162 mgs of aspirin for most indications. The Company intended to seek an indication for the secondary prevention of cardiovascular disease in patients at risk for gastric ulcers. During the Type A meeting held in August 2012, the FDA confirmed its preference to have both PA32540 and a lower dose version available in the market so that physicians can have both a low and high dose option available, and agreed that, if both dosage strengths were included in the NDA and subsequently approved, the indications for both will be consistent with the full range of indications described in the current aspirin monograph.
The NDA in April should have both PA's filed. Consider the safety and effectiveness of both PA's, and considering we are not talking about some experimental Cancer Drug, I see no reason whatsoever that the FDA will not approve both by the end of the year.
