US FDA advisers recommend against Otsuka's PTSD combination treatment
The panel voted 10-1 to say the available data does not establish the efficacy of the drug, brexpiprazole, in combination with Zoloft, chemically known as sertraline, for treating the condition. Its decision is in line with the FDA staff reviewers' assessment on Wednesday.
Otsuka's application was based on the data from one mid-stage and two late-stage studies testing the combination treatment compared to sertraline plus placebo. It had failed to meet the main goal of significantly reducing severity of PTSD symptoms in one of the late-stage studies compared to sertraline and placebo.
PTSD, a disorder caused by very stressful events, affects about 4% of U.S. adults and is commonly associated with war veterans. But natural disasters, abuse or other trauma may also trigger the condition in civilians.
"We simply cannot negate one negative study and say we are going to approve based on two other positive studies," said panelist Pamela Shaw, biostatistician at Kaiser Permanente.
Otsuka did not immediately respond to a Reuters request for comment.
The advisers discussed possible side-effects such as weight gain and movement disorders associated with long-term use of antipsychotics, but noted that the combination may be a better treatment option for patients who respond poorly to sertraline alone.
"The big question for me is knowing that antipsychotics can cause real problems, especially with long-term use, and the modest benefit that the combination treatment potentially can offer," said panelist Walter Dunn, assistant clinical professor of psychiatry at university of California Los Angeles.
The FDA, originally set to decide on the company's application by February 8, delayed its decision to seek the advisory panel's input. The agency has not set a new action date for the drug.
The health regulator typically follows the advice of its expert advisers, but is not required to do so.
If approved, the combination drug would be the first PTSD treatment to gain U.S. nod in more than two decades after Zoloft and GSK's (GSK.L), opens new tab Paxil.
Brexpiprazole, branded as Rexulti, is approved in the U.S. to treat agitation in patients with Alzheimer's disease as well as for adults with major depressive disorder and schizophrenia.
The drug is being co-developed by Otsuka and Danish drugmaker Lundbeck (HLUNa.CO), opens new tab.
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These microbes replace themselves very quickly, but if someone is drinking alcohol every night, say, it will be very damaging to the gut microbiome.' What to have instead: Guinness or alcohol-free beer 'Sadly, alcohol in general is bad for your gut,' says Prof Spector. 'However, darker beers tend to have more polyphenols, so if you enjoy an occasional tipple, opt for something dark.' A good example is Guinness which is known to have high levels of polyphenols. Alcohol-free beers are also growing in popularity, though Moore points out that they tend to have a high sugar content. 'The debate is then, 'Is the alcohol or the sugar worse for the gut microbiome?' I think either is probably fine in real moderation, but neither are great on a regular basis.' 7. Dark spirits Dark spirits like whisky, brandy and rum are particularly harmful because they contain high levels of congeners, natural compounds that are associated with more hangover severity and gut inflammation. 'These congeners are chemical compounds that come from the process of making darker spirits, as opposed to vodka and gin,' says Moore. What to have instead: tequila/mezcal 'All spirits, regardless of colour, are bad for your gut health,' warns Prof Spector. However, if you're looking for a slightly less destructive option, studies suggest that tequila and mezcal could be a comparatively healthier choice. 'Both are made from the agave plant, which is full of inulin, which is a very potent prebiotic fibre,' says Moore. 'If you want to drink a spirit, your best option is to drink tequila mixed with some water kefir. That way you've actually got live microbes in the water kefir and prebiotics in the tequila. So you could potentially be getting something beneficial from an alcoholic drink.' What should we be drinking to maintain optimal gut health? Water is the ideal option, but it can get boring so it makes sense to find tasty, healthy alternatives. 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Studies show that regularly consuming tea can reduce the number of 'bad' bacteria and increase levels of more beneficial microbes. However, green tea seems to be better than black.' Coffee, he adds, is also beneficial. 'It contains fibre and polyphenols, both of which can feed your gut microbiome. In fact, a study found one microbe called Lawsonibacter asaccharolyticus. This species was much more common in people who drank coffee and was associated with a marker of good metabolic and gut health. In general, it seems that drinking up to five cups per day can support your gut health. And if caffeine doesn't agree with you, decaffeinated coffee is just as good for your microbiome.' The main problem with tea and coffee, of course, is what people put in them. Sugar should be cut out, ideally, and if you're drinking multiple cups per day, add only a small amount of milk – though Moore does point out that for some people, drinking black coffee on an empty stomach may not be advisable: 'It can be quite acidic and disruptive to the digestive system, so adding a bit of milk can soften it and help the body manage the acidity better.'
