Eligard: XXXX in a novel sustained-release delivery system.

@entity172 @entity4396 @entity3086 @entity19040 @entity263 @entity251 @entity1 @entity10925 @entity342
@entity342 deprivation as a treatment for @entity263 has evolved since the pioneering studies of Huggins and Hodges 60 years ago using surgical castration or @entity172 treatments. The most common hormonal treatments today use injections of @entity4396 ( @entity4396 ) agonists. The US Food and Drug Administration (FDA) has approved 5 @entity4396 agonist formulations for treatment of @entity263 in the United States. Of these approved products, 3 involve different delivery systems for the @entity4396 superagonist @entity3086 . Sustained-release formulations of 2 distinct @entity4396 agonists, @entity10925 and @entity19040 , are also commercially available. This review focuses on new data on a novel formulation of @entity3086 (Eligard; Atrix Laboratories Inc., Fort Collins, CO) that incorporates a unique mixture of selected polymers and solvents to achieve sustained drug delivery after subcutaneous injection. The FDA has approved 1-month and 3-month formulations of Eligard, and 4-month and 6-month products are in development. In clinical trials, Eligard achieves reliable and sustained suppression of serum @entity251 to castration levels (< or =50 ng/dL). Of the @entity1 treated with the 1-month and 3-month formulations, 98% (115 of 117) and 94% (104 of 111), respectively, reached @entity251 levels of < or =20 ng/dL. Breakthroughs, defined as @entity251 levels >50 ng/dL after achievement of castration levels, occurred rarely at 0% (0 of 117) for the 1-month and at 0.9% (1 of 111) for the 3-month formulations in @entity1 receiving Eligard. The degree of disease control and the adverse-events profile are commensurate with the effectiveness of the @entity251 suppression; the incidence of severe hot flashes is actually lower than anticipated. Additional studies with these novel formulations are warranted.
