Hydrocodone bitartrate (Zohydro ER) with modified formulation designed with abuse-deterrent properties has been submitted to the FDA as a supplemental New Drug Application (sNDA).1 This new capsule formulation contains additional inactive ingredients that are intended to make the product more difficult to abuse by injection and nasal insufflation. The manufacturer anticipates review of their submission in the first quarter of 2015. If approved, this product will replace the currently marketed product that does not have abuse-deterrent properties. The product is indicated for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are not adequate.
Secukinumab (AIN457) is a fully human monoclonal antibody that selectively blocks IL-17A.2 Secukinumab in patients with adult-onset psoriatic arthritis (PsA) has met primary and major secondary endpoints in two pivotal Phase 3 clinical trials (FUTURE 1 and FUTURE 2), showing superiority to placebo in over 1,000 patients. Endpoints included improving PsA signs and symptoms, preventing joint damage and improving peripheral joint disease, compared with placebo. While at the same time, patients had clear or almost clear skin (Psoriasis Area Severity Index 90). Both FUTURE 1 and 2 are randomized, placebo-controlled, multicenter studies designed to establish secukinumab efficacy in PsA patients in comparison to placebo. In addition, the studies were designed to assess secukinumab tolerability and safety. The ACR20 was the primary endpoint in these trials, and the agent was well tolerated. No new safety signals were identified. It is also being investigated to treat ankylosing spondylitis (AS), moderate-to-severe plaque psoriasis and rheumatoid arthritis (RA).
On Sept. 18, a combined Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement of FDA met to discuss limitation on the use of testosterone products.3 They unanimously voted on modifying product labeling for testosterone-replacement products used for men with congenital or acquired primary hypogonadism, including such conditions as cryptorchidism, Klinefelter’s syndrome or testicular damage from chemotherapy or heavy metals. These uses were not questioned.
The benefit of [testosterone-replacement products] is unknown in patients with idiopathic hypogonadism.
Use for “age-related or idiopathic” hypogonadism was questioned. This is currently worded as “hypogonadotropic hypogonadism (congenital or acquired): Idiopathic gonadotropin or luteinizing-hormone–releasing (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.” The panel recommended the completion of large studies to show both clinical benefit and product safety. Currently, the benefit is unknown in patients with idiopathic hypogonadism. The ambiguous wording has led to increased testosterone use in men with potentially low testosterone (low-T) who have signs and symptoms of age-related low levels, but many have normal levels or have not had their levels tested. In addition, studies have shown that testosterone use may increase cardiovascular risk in men who use the product. Additionally, in 25% of testosterone-replacement product users, no levels were obtained prior to treatment, and 21% of users never had levels checked during treatment.