- First, health care professionals have been unwilling to try (or adopt) NOCTIVA. Physicians almost exclusively treat their patients with other agents that target conditions such as overactive bladder and prostate due to the high prevalence of co-morbidity between these conditions and nocturia due to nocturnal polyuria.
- Second, underlying concerns with regard to the potential risks of a serious side effect associated with the active ingredient in NOCTIVA (desmopressin acetate), based on prior experience with older formulations of the same active ingredient, have resulted in a hesitancy overall by health care professionals to adopt and/or try NOCTIVA for their patients.
- Third, serum sodium monitoring requirements, which are not necessarily in the ordinary course for physicians treating patients suffering from nocturia due to nocturnal polyuria, have inhibited healthcare professionals’ overall willingness to broadly adopt NOCTIVA.
- Lastly, given the evolution of patient benefit designs and the restrictions managed care companies have placed on NOCTIVA, despite significant efforts, during the first approximately nine months of commercialization, over 55% of all prescriptions were dispensed for free resulting in no corresponding positive gross margin. Furthermore, when combined with the additional qualified and eligible financial assistance provided for insured beneficiaries with a covered benefit for NOCTIVA, the resulting gross margin has been substantially lower than originally assumed. For these and other reasons, approximately $80 million in additional investments since September 2017 (exclusive of the Initial Payment and Launch Payment) has yielded less than $3 million in net sales.
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