Ties to drugmaker left out of postpartum depression drug study recap
Rating
Newly Published Results Show Investigational Treatment Brexanolone Consistently Reduced Depressive Symptoms Across Three Postpartum Depression Trials, Supporting Submission for FDA Approval
Our Review Summary
An injectable drug, brexanolone, showed some effectiveness in treating postpartum depression in two phase 3 double-blind randomized controlled trials including 247 women from 30 different research centers, according to research led by the University of North Carolina. Their research showed reductions in reported depression symptoms among study volunteers receiving either the drug or placebo (17 points for those on the drug, compared to a reduction of 12.8 points reduction for those on a placebo).
This study about a potential new drug is important, but the way it is reported leaves holes for the reader. The research was funded by the drug maker, Sage Therapeutics, and the two researchers quoted in the release have financial links to the drug manufacturer. The release should have given us more context about the amount of improvement, and been straightforward about the conflicts of interest.
Why This Matters
The American Psychological Association estimates that up to one-in-seven women in the US suffer from some form of postpartum depression, and this disorder can linger for some of them and interfere with their bonding with their child. Existing treatments, such as talk therapy and antidepressants are not always successful and may take weeks to improve the situation.
If approved by the FDA, the drug could be an advance in the treatment of postpartum depression which is common and sometimes serious.
Criteria
Not Satisfactory
The news release does not mention costs. While a new therapy may not have an established price, the release could have stated “no price is available for this drug.” What would be even better is some context for what women suffering from postpartum pay typically for counseling and medications.
Satisfactory
The release notes that there was a reduction in depressive symptoms of 17 points for those on the drug, and 12.8 for those in the placebo group based on the Hamilton Depression Rating Scale. The absolute reduction in the rating scale is given for each group. This information would have been much more helpful if the release also clarified the magnitude of the scale and whether a 4.2-point difference is clinically meaningful.
Satisfactory
The release contains one somewhat vague sentence on harms.
The most common (≥10% of subjects) adverse events following during brexanolone injection administration were headache, dizziness and somnolence.
Readers would also be interested in details on whether the drug is safe for nursing infants. That’s not mentioned.
Satisfactory
The double-blinded randomized trials are described in detail and readers are able to judge the quality of the evidence. The published study includes an important limitation of the research that’s not mentioned in the release: The trials assessed women for only 30 days; the effects of the treatment beyond 30 days are “unknown.”
Satisfactory
There is no disease mongering. The release explains how common postpartum depression is worldwide.
Not Satisfactory
The release notes that Sage Therapeutics funded the research.
Sage Therapeutics is the developer of brexanolone injection and sponsor of the trials. A New Drug Application is currently under review by the FDA and brexanolone injection has been granted Breakthrough Therapy Designation. The FDA has assigned a Prescription Drug User Fee Act target date of December 19, 2018.
What the release doesn’t tell us is that both quoted researchers disclosed financial ties with Sage Therapeutics. This information was included in the studies published in the Lancet.
SM-B reports personal fees from MedScape and grants from Sage Therapeutics, awarded to the University of North Carolina … DRR reports personal fees and has stock options in Sage Therapeutics….
Satisfactory
The release mentions that women currently can receive antidepressants for postpartum depression, but that the new drug being studied goes to work relieving symptoms faster than traditional antidepressants — days rather than weeks.
Satisfactory
The release notes that the drug is currently under FDA review, with a decision on its approval expected by the end of the year.
Satisfactory
The release notes that the new drug would be a novel treatment for postpartum depression, if approved.
Satisfactory
There is no unjustifiable language.
Total Score: 8 of 10 Satisfactory
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