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"The approval of this new add-on treatment option is critical for adultssuffering from depression who cannot find sufficient relief for their symptomswith antidepressants alone," said Madhukar Trivedi, M.D., Professor and Chief-Division of Mood Disorders, University of Texas Southwestern Medical School,Dallas, Texas. "Now physicians have a proven new option they can add to theirpatients' antidepressant treatments to help them feel better and relieveunresolved depressive symptoms."
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The approval is based on results from two six-week, double-blind,randomized, placebo-controlled, multicenter studies (n=743). The results fromboth studies demonstrated significant improvement in depressive symptoms inadult patients with a primary diagnosis of major depressive disorder who hadexperienced an inadequate response* to monotherapy with one or more ADTs inthe current episode and then added ABILIFY to their treatment regimens.
"We are committed to helping those who suffer from depression, one of theleading causes of disability in the United States and worldwide," said ElliottSigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer andPresident, Research and Development, Bristol-Myers Squibb. "This approval isa reflection of our ongoing commitment to provide innovative therapies, suchas ABILIFY, to help adults living with depression."
"We are pleased that ABILIFY has achieved this important milestone as thefirst medication approved as adjunctive treatment for adults with majordepressive disorder," said Taro Iwamoto, Ph.D., Chief Executive Officer,President and Chief Operating Officer, Otsuka Pharmaceutical Development andCommercialization, Inc. "This new add-on treatment option for depressionrepresents hope for many adults suffering from this debilitating illness."
Major depressive disorder affects millions of U.S. adults at some point intheir lives.(2) A recent study evaluated different treatment approaches,including adjunctive medications and switching strategies, in patients withMDD.(1) The study found that 63 percent of patients did not achieve adequaterelief of depressive symptoms following the initial treatment with anantidepressant alone.(1) Additionally, the study demonstrated that the use ofadjunctive medications in treatment may be useful to improve unresolveddepressive symptoms.(1)
Clinical Trial Design and Findings
Two six-week, double-blind, randomized, placebo-controlled, multicenterstudies evaluated the efficacy and safety of add-on ABILIFY in adult patientswith a primary diagnosis of major depressive disorder who had experienced aninadequate response to prior antidepressant therapy (one to three courses) inthe current episode.
After an eight-week prospective treatment phase with one ADT plus single-blind placebo to confirm inadequate response to ADT, 743 participants entereda six-week randomized treatment phase during which they continued their ADTplus double-blind adjunctive placebo or adjunctive ABILIFY. All studyparticipants received one of the commonly prescribed ADTs, including selectiveserotonin reuptake inhibitors (SSRIs): Lexapro(R) (escitalopram), Prozac(R)(fluoxetine), Paxil CR(R) (paroxetine controlled-release), Zoloft(R)(sertraline); or a serotonin-norepinephrine reuptake inhibitor (SNRI): EffexorXR(R) (venlafaxine extended release). The dosage range for adjunctive ABILIFYwas 2-20 mg/day (15 mg/day was the maximum dose for patients
