ABBOTT/BURROUGHS WELLCOME's HYTRIN COMARKETING GIVES SUPPORT IN BOTH HOSPITAL AND MD OFFICE; HYTRIN IS FIRST ONE-A-DAY ALPHA BLOCKER ANTIHYPERTENSIVE

Abbott and Burroughs Wellcome's Hytrin (terazosin) comarketing will involve 1400 detailers split evenly between the two firms. The comarket arrangement gives Hytin support in the hospital market via Abbott and the physician's office through Burroughs Wellcome. Abbott's NDA for Hytrin, in the first one-a-day alpha-blocker/antihypetensive, was approved by FDA Aug. 7. The Hytrin NDA took almost four years to complete; Abbott submitted the NDA for Hytrin September 30, 1983. It took two-and-a-half years to get to an FDA advisory committee review. The drug reached the "approvable" stage on July 17, this summer. FDA classified the antihypertensive as a 1C drug, a new chemical entity with little or no therapeutic gain. Hytrin is indicated for "the treatment of hypertension [and] it can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents," the approved labeling states. The initial dose is "1 mg at bedtime" and may be "slowly increased to achieve the desired blood pressure response." Labeling states that the recommended dose range is "1 mg to 5 mg administered once a day; however some patients may benefit from doses as high as 20 mg per day." The pharmacodynamics section of the labeling notes that Hytrin has an ancillary action to reduce cholesterol. Labeling states that "patients receiving terazosin monotherapy had a small but statistically significant decrease (a 3% fall) compared to placebo in total cholesterol and the combined low density and very-low-density lipoprotein fractions." Abbott's application for Hytrin is the first electronic NDA to be approved under FDA's electronic NDA review experiment. The company submitted both electronic and paper NDAs for Hytrin. As the first test-case electronic NDA, the Hytrin submission is probably not indicative of the potential time-savings from electronic formatting. Cardio-Renal Division Director Raymond Lipicky, MD, however, noted in a February report that the electronic NDA allowed him to complete a secondary review of the Hytrin application within two days, a much shorter time than a paper NDA would have taken.