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J&J's Esketamine Fails to Meet Endpoint in Phase III Study

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Johnson & Johnson (JNJ - Free Report) announced data from a phase III study, evaluating its investigational esketamine nasal spray in combination with newly initiated oral antidepressant (NIOD) on patients with treatment-resistant depression as compared to placebo nasal spray plus the NIOD. The study failed to demonstrate statistical significance for the primary endpoint.

The primary objective of the program was to show that switching patients to a fixed dose of esketamine (56 mg or 84 mg) along with NIOD led to better improvement in depressive symptom in comparison to a shift to placebo coupled with NIOD.

The combination failed to demonstrate a statistically significant reduction of depressive symptoms after being administered with the 84 mg dose of esketamine nasal spray plus NIOD compared with placebo and NIOD. Therefore, per the prespecified analysis plan, the 56 mg dose could not be formally evaluated through this program. Improvement in symptoms was assessed by the change in a depression severity rating scale score from baseline to four weeks.

However, the primary as well as key secondary endpoints numerically favored the esketamine arm compared with the placebo arm. Results from the same also demonstrated superior safety and tolerability of esketamine combined with NIOD as compared to earlier assessments.

Findings from the evaluation were presented at the Ninth Biennial Conference of the International Society for Affective Disorders (ISAD) and the Houston Mood Disorders Conference that took place in Houston, TX from Sep 20 to Sep 22, 2018.

This study is one of the five pivotal phase III examinations on esketamine nasal spray. Based on this, a new drug application was filed in the United States earlier this month.

Shares of J&J have gained 2.3% so far this year, compared with the industry’s increase of 7.2%.

 

We remind investors that the FDA has granted a Breakthrough Therapy Designation to esketamine nasal spray for treatment-resistant depression and a major depressive disorder with an imminent risk for suicide.

The company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency for esketamine, later in 2018.

 

Zacks Rank & Stocks to Consider

J&J carries a Zacks Rank #3 (Hold). Some better-ranked large-cap drug stocks are Roche Holding AG (RHHBY - Free Report) , Eli Lilly & Company (LLY - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) . While Roche sports a Zacks Rank #1 (Strong Buy), Lilly and Bristol-Myers carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Roche’s earnings estimates have moved 6.7% north for 2018 and 6% for 2019 over the past 60 days.

Lilly’s earnings estimates have been raised 1.9% for 2018 and 2% for 2019 over the past 60 days. The stock has rallied 24% in the past three months.

Bristol-Myers’ earnings estimates have been revised 3.4% upward for 2018 and 2.7% for 2019 over the past 60 days. The stock has gained 13.9% in the past three months.

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