FDA hands back Adamis' ap­pli­ca­tion for an ED drug, look­ing for more da­ta

The mi­cro cap San Diego-based biotech Adamis has stum­bled bad­ly in its at­tempt to get a low­er-cost erec­tile dys­func­tion drug on the mar­ket.

The spe­cial­ty phar­ma­ceu­ti­cal com­pa­ny — which fo­cus­es on de­vel­op­ing cheap­er drugs for var­i­ous dis­or­ders — said the FDA had deemed its mar­ket­ing ap­pli­ca­tion in­com­plete, hand­ing back the ap­pli­ca­tion with a re­fusal-to-file no­tice and in­di­cat­ing the biotech did not in­clude suf­fi­cient da­ta to per­mit re­view. The ex­per­i­men­tal drug is a fast-dis­in­te­grat­ing sub­lin­gual ver­sion of tadalafil.

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