1.0Public Citizenhttps://www.citizen.orgDiane Krauthamerhttps://www.citizen.org/author/dkrauthamer/Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding Extended-Release Morphine Sulfate (Arymo) - Public Citizenrich600338<blockquote class="wp-embedded-content" data-secret="fIdB3RLXVw"><a href="https://www.citizen.org/article/testimony-before-the-fdas-drug-safety-and-risk-management-and-anesthetic-and-analgesic-drug-products-advisory-committees-regarding-extended-release-morphine-sulfate-arymo/">Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding Extended-Release Morphine Sulfate (Arymo)</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://www.citizen.org/article/testimony-before-the-fdas-drug-safety-and-risk-management-and-anesthetic-and-analgesic-drug-products-advisory-committees-regarding-extended-release-morphine-sulfate-arymo/embed/#?secret=fIdB3RLXVw" width="600" height="338" title="“Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding Extended-Release Morphine Sulfate (Arymo)” — Public Citizen" data-secret="fIdB3RLXVw" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script type="text/javascript">
/* <![CDATA[ */
/*! This file is auto-generated */
!function(d,l){"use strict";l.querySelector&&d.addEventListener&&"undefined"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!/[^a-zA-Z0-9]/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret="'+t.secret+'"]'),o=l.querySelectorAll('blockquote[data-secret="'+t.secret+'"]'),c=new RegExp("^https?:$","i"),i=0;i<o.length;i++)o[i].style.display="none";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute("style"),"height"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):"link"===t.message&&(r=new URL(s.getAttribute("src")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener("message",d.wp.receiveEmbedMessage,!1),l.addEventListener("DOMContentLoaded",function(){for(var e,t,s=l.querySelectorAll("iframe.wp-embedded-content"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute("data-secret"))||(t=Math.random().toString(36).substring(2,12),e.src+="#?secret="+t,e.setAttribute("data-secret",t)),e.contentWindow.postMessage({message:"ready",secret:t},"*")},!1)))}(window,document);
/* ]]> */
</script>
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen opposed approval of extended-release morphine sulfate (Arymo) because of serious concerns about increased risk of abuse, given its easy manipulability and unsatisfactory performance in oral human abuse likeability studies. We also urged that the FDA’s guidance for industry, “Abuse-Deterrent Opioids—Evaluation and Labeling,” be withdrawn and replaced with a regulation more favorable to patients than to opioid makers.https://www.citizen.org/wp-content/uploads/public_citizen_shared_link.jpg1200628