{"id":1355,"date":"2013-07-08T13:12:51","date_gmt":"2013-07-08T17:12:51","guid":{"rendered":"http:\/\/lacertabio.com\/?p=1355"},"modified":"2013-07-08T13:12:51","modified_gmt":"2013-07-08T17:12:51","slug":"treatments-for-hot-flashes-winners-and-losers","status":"publish","type":"post","link":"https:\/\/lacertabio.com\/treatments-for-hot-flashes-winners-and-losers\/","title":{"rendered":"Treatments for Hot Flashes: Winners and Losers"},"content":{"rendered":"<p> <\/p>\n<p> <\/p>\n<figure style=\"width: 300px\" class=\"wp-caption alignleft\"><a href=\"http:\/\/commons.wikipedia.org\/wiki\/File:Vincent_Willem_van_Gogh_002.jpg\" target=\"_blank\"><img fetchpriority=\"high\" decoding=\"async\" class=\"zemanta-img-inserted zemanta-img-configured\" title=\"On the Threshold of Eternity\" alt=\"On the Threshold of Eternity\" src=\"http:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/3\/38\/Vincent_Willem_van_Gogh_002.jpg\/300px-Vincent_Willem_van_Gogh_002.jpg\" width=\"300\" height=\"385\" \/><\/a><figcaption class=\"wp-caption-text\">He can’t figure the FDA out either…<\/figcaption><\/figure>\n<p>In a <a title=\"F.D.A. Approves a Drug for Hot Flashes\" href=\"http:\/\/www.nytimes.com\/2013\/06\/29\/business\/fda-approves-a-drug-for-hot-flashes.html?_r=0\" target=\"_blank\">surprise decision last week<\/a>, the US FDA decided to approve Brisdelle, a low-dose formulation of paroxetine, for the treatment of menopausal hot flashes. This comes on the heels of the <a title=\"FDA Issues Complete Response Letter on SEFELSA\u2122 New Drug Application\" href=\"http:\/\/investor.depomedinc.com\/phoenix.zhtml?c=97276&p=irol-newsArticle&ID=1826033&highlight=\" target=\"_blank\">FDA granting a CRL<\/a> to Depomed for their sustained release version of gabapentin for the same indication.<\/p>\n<p>Interestingly, the Advisory committee recommended against approval for both paroxetine (10-4 vote) and gabapentin (12-2), on concerns that both agents would increase the risk of patients developing suicidal thoughts.<\/p>\n<p>Meanwhile, off-label use of both agents remains significant, as they represent two of the only non-hormonal options that women have to treat moderate to severe menopausal hot flashes.<\/p>\n<p>It should be noted that the Noven formulation is already on the market as <a title=\"Pexeva\" href=\"http:\/\/www.pexeva.com\/\" target=\"_blank\">Pexeva<\/a>, and is indicated for major depressive disorder and related disorders. Depomed has a different formulation of gabapentin on the market (<a title=\"Gralise\" href=\"http:\/\/www.gralise.com\/\" target=\"_blank\">Gralise<\/a>) for postherpetic neuralgia.<\/p>\n<p>An analysis by <a title=\"FDA Committee to Review Depomed\u2019s Gabapentin and Hisamitsu\u2019s Paroxetine for Menopause-Associated VMS\" href=\"http:\/\/www.adverseevents.com\/monitor\/2013\/03\/01\/fda-committee-to-review-depomeds-gabapentin-and-hisamitsus-paroxetine-for-menopause-associated-vms\/\" target=\"_blank\">AdverseEvents.com<\/a>\u00a0notes that Gralise has been associated with 22 serious adverse events from January, 2011 through August, 2012. These included diarrhea, dizziness, and dyskinesia. Six hospitalizations and one death were potentially linked to Gralise.<\/p>\n<p>Similarly, Pexeva was associated with 80 adverse events from 2003-2012, with anger, anxiety, and contemplated suicide as the most common ones.<\/p>\n<p><strong><span style=\"color: #008000;\">Who won? Who lost?<\/span><\/strong><\/p>\n<p>When physicians select treatment for hot flashes, it’s likely many outside the KOL community will shift some of their off-label use of gabapentin towards on-label Pexeva once it’s on the market and labelled and detailed (assuming it will be widely reimbursed, which is a separate issue).<\/p>\n<p>So Noven is the winner and Depomed is the loser?<\/p>\n<p>Wrong.<\/p>\n<p>It’s the patients who lost (again).<\/p>\n<p>By this action, the FDA is removing gabapentin as a viable option for patients and their physicians.<\/p>\n<p>Now gabapentin has been around since 1994. Physicians have literally decades of experience with this agent across multiple indications and patient populations.<\/p>\n<p>And, to be fair, the <a title=\"Suicidal Behavior and Ideation and Antiepileptic Drugs\" href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm100190.htm\" target=\"_blank\">FDA has issued warnings<\/a> about suicidal ideation with gabapentin and other antiepileptic drugs for several years. However, similar concerns regarding <a title=\"Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and Pediatric Advisory Committee.\" href=\"http:\/\/www.fda.gov\/ohrms\/dockets\/ac\/04\/briefing\/2004-4065b1-10-TAB08-Hammads-Review.pdf\" target=\"_blank\">paroxetine have been noted<\/a> by the FDA, most notably in the pediatric population.<\/p>\n<p>It’s far too simplistic for us to say that one drug is worse than another when it comes to side effects. It will take some clever meta-analyses to sort that out.<\/p>\n<p><span style=\"color: #444444;\">Regardless, what many of us thought was a slam dunk approval for gabapentin turned out quite differently, and for reasons that remain unclear.\u00a0<\/span><\/p>\n<h6 class=\"zemanta-related-title\" style=\"font-size: 1em;\">Related articles<\/h6>\n<ul class=\"zemanta-article-ul zemanta-article-ul-image\" style=\"margin: 0; padding: 0; overflow: hidden;\">\n<li class=\"zemanta-article-ul-li-image zemanta-article-ul-li\" style=\"padding: 0; background: none; list-style: none; display: block; float: left; vertical-align: top; text-align: left; width: 84px; font-size: 11px; margin: 2px 10px 10px 2px;\"><a style=\"box-shadow: 0px 0px 4px #999; padding: 2px; display: block; border-radius: 2px; text-decoration: none;\" href=\"http:\/\/www.medicaldaily.com\/articles\/16993\/20130630\/hot-flashes-fda-brisdelle-menopause-non-hormonal-paxil-ssri.htm\" target=\"_blank\"><img decoding=\"async\" style=\"padding: 0; margin: 0; border: 0; display: block; width: 80px; max-width: 100%;\" alt=\"\" src=\"http:\/\/i.zemanta.com\/181206062_80_80.jpg\" \/><\/a><a style=\"display: block; overflow: hidden; text-decoration: none; line-height: 12pt; height: 80px; padding: 5px 2px 0 2px;\" href=\"http:\/\/www.medicaldaily.com\/articles\/16993\/20130630\/hot-flashes-fda-brisdelle-menopause-non-hormonal-paxil-ssri.htm\" target=\"_blank\">FDA Approves First Non-Hormonal Treatment Brisdelle For Hot Flashes; Contains SSRI Paxil<\/a><\/li>\n<li class=\"zemanta-article-ul-li-image zemanta-article-ul-li\" style=\"padding: 0; background: none; list-style: none; display: block; float: left; vertical-align: top; text-align: left; width: 84px; font-size: 11px; margin: 2px 10px 10px 2px;\"><a style=\"box-shadow: 0px 0px 4px #999; padding: 2px; display: block; border-radius: 2px; text-decoration: none;\" href=\"http:\/\/www.scienceworldreport.com\/articles\/7857\/20130629\/brisdelle-non-hormal-treatment-hot-flashes-approved-fda.htm\" target=\"_blank\"><img decoding=\"async\" style=\"padding: 0; margin: 0; border: 0; display: block; width: 80px; max-width: 100%;\" alt=\"\" src=\"http:\/\/i.zemanta.com\/181046804_80_80.jpg\" \/><\/a><a style=\"display: block; overflow: hidden; text-decoration: none; line-height: 12pt; height: 80px; padding: 5px 2px 0 2px;\" href=\"http:\/\/www.scienceworldreport.com\/articles\/7857\/20130629\/brisdelle-non-hormal-treatment-hot-flashes-approved-fda.htm\" target=\"_blank\">Brisdelle: Non-Hormal Treatment for Hot Flashes Approved by FDA<\/a><\/li>\n<\/ul>\n<div class=\"zemanta-pixie\" style=\"margin-top: 10px; height: 15px;\"><img decoding=\"async\" class=\"zemanta-pixie-img\" style=\"border: none; float: right;\" alt=\"\" src=\"http:\/\/img.zemanta.com\/pixy.gif?x-id=e187b669-df0d-4e4b-8091-208c7950a6f4\" \/><\/div>\n","protected":false},"excerpt":{"rendered":"<p> In a surprise decision last week, the US FDA decided to approve Brisdelle, a low-dose formulation of paroxetine, for the treatment of menopausal hot flashes. This comes on the heels of the FDA granting a CRL to Depomed for their sustained release version of gabapentin for the same indication. Interestingly, the Advisory committee […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false},"version":2}},"categories":[14],"tags":[],"class_list":["post-1355","post","type-post","status-publish","format-standard","hentry","category-drug-development","entry"],"jetpack_publicize_connections":[],"jetpack_sharing_enabled":true,"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/lacertabio.com\/wp-json\/wp\/v2\/posts\/1355","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lacertabio.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lacertabio.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lacertabio.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/lacertabio.com\/wp-json\/wp\/v2\/comments?post=1355"}],"version-history":[{"count":0,"href":"https:\/\/lacertabio.com\/wp-json\/wp\/v2\/posts\/1355\/revisions"}],"wp:attachment":[{"href":"https:\/\/lacertabio.com\/wp-json\/wp\/v2\/media?parent=1355"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lacertabio.com\/wp-json\/wp\/v2\/categories?post=1355"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lacertabio.com\/wp-json\/wp\/v2\/tags?post=1355"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}