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The main media outlets hastened to criticize the support provided by the FDA's (Food and Drug Administration) expert panel to sufentanil sufentanil tablet (Dsuvia) as a treatment for pain seemed to have lost crucial details when writing their titles.
This week, the FDA's Anesthetic and Analgesic Drugs Advisory Committee voted 10 to 3 in favor of the Marketing Authorization recommendation for the 30 mcg tablet of Sufentanil from AcelRx. Pharmaceuticals. The support vote will follow the new opioid (DNA) request to the FDA, which will decide whether to approve it for the treatment of moderate to severe acute pain in institutions under medical supervision for adult patients.
The committee's vote significantly covered the power of the drug – "The FDA could approve an opioid 10 times stronger than fentanyl," read an article. Rolling stone title, while others have pointed out its effects as "500 times more powerful than morphine".
The news of the decision – as well as even more different measures of the strength of the drug – has reached the political forum. Sen. Edward J. Markey (D-Mass) posted a statement urging the FDA to reject the NDA for sufentanil, citing opioid "up to 10 times more potent than fentanyl and 1000 times more potent than morphine ". . "
"An opioid a thousand times more powerful than morphine is a thousand times more likely to abuse and a thousand times more likely to kill," said Markey. "Even in the midst of the worst drug crisis our country has ever seen, the FDA is doing its utmost to approve a new, extremely heavy painkiller that would only worsen the epidemic of opioids. . "
Jeff Gudin, MD, director of pain management and palliative care at the hospital and medical center in Englewood, New Jersey, has drawn the attention of some of the headlines. In an interview with MD Magazine®, Gudin noted that the difference in strength between sufentanil and morphine and fentanyl was omitted: sufentanil tablets would not be available over the counter or on prescription.
"I agree with the recommendation of the advisory council for approval," said Gudin. "Even though we are in the midst of an opioid crisis, my understanding is that it will only be administered by health professionals in a hospital or similar facility."
The data
In fact, data submitted to the FDA in support of NDA submission by AcelRx compared the analgesic efficacy of the sufentanil tablet to a placebo in patients with moderate to severe acute pain following abdominal surgery. outpatient, which would be strictly indicated.
The US multicenter trial, which randomized patients 2: 1 to receive either a 30 mcg treatment as needed or a placebo, limited treatment to 48 hours post-procedure. Patients were offered standard postoperative pain management and required ≥4 pain intensity on an 11-point numerical evaluation scale within 8 hours to be randomized for treatment. Patients can not receive sufentanil beyond 24 hours unless they continue to report ≥ 4 pain intensity.
The investigators asked patients to wait at least 1 hour between doses and administered a rescue medication containing 1 mg morphine intravenously (IV) at the earliest 10 minutes after the administration of the treatment.
Of the 161 patients randomized to receive the study drug, the majority were under 65 years of age and female. The most common surgery in patients was abdominoplasty, followed by laparoscopic abdominal surgery and hernioplasty. The majority of patients who received sufentanil received 12 to 24 hours of treatment, while fewer patients receiving placebo achieved one or the other.
Sufentanil patients reported significant pain relief after 54 minutes, while patients reported a median delay of 84 minutes. During the first 12 and 24 hour study periods, the mean duration between doses of sufentanil administered was 3 to 3.5 hours.
In the safety assessment, the investigators noted that more patients treated with sufentanil at 30 mcg experienced nausea (n = 35). [32.7%]) and vomiting (8 [7.5%]), that placebo-treated patients (16, 1 [29.6%, 1.9%], respectively).
The most common adverse events in patients receiving treatment were headache (22). [20.6%]), vertigo (6) [5.6%]) and hypotension (6 [5.6%]).
Additional data presented at the American Society of Anesthesiologists (ASA) in San Francisco, California, this week showed the efficacy and safety of sufentanil versus placebo in postoperative patients after a bunionectomy or abdominal surgery. In both open, single arm trials, therapies were administered to elderly patients, often with comorbidities, in emergency departments.
The researchers reported statistically significant improvements in the difference in pain intensity over 12 hours in patients treated with sufentanil compared to those on placebo. Nausea was again the most commonly reported adverse event among patient populations.
The correction
NDA AcelRx gave special importance to the safety of its patients because the company received a full response letter (CRL) instead of additional FDA safety data last year. CSF has mainly recommended that additional data on at least 50 patients treated at the maximum suggested rate of tagging show its safety. He also recommended and that some changes to his mode of employment be corrected as part of another study.
Despite the fact that CRLs prevented the US market from taking into account the US market, Dsuvia was approved a month later by the European Medicines Agency in June 2018.
In a statement regarding ASA data, Jacob Hutchins, MD, associate professor at the University of Minnesota Medical Center, pointed to the need for pain management options in a surgical setting.
"Pain is the leading cause of delay in leaving outpatient surgery centers and the main reason for unexpected admissions to the hospital," said Hutchins. "Inadequate management of pain during the perioperative period results in unnecessary suffering and discomfort, potential analgesic benefits in patients requiring non-invasive management of acute pain."
Gudin echoed his potential to "play a role" in ambulatory care – a role similar to that of painkiller IV options such as morphine, only in supervised and managed circumstances by the provider.
"I certainly agree that in the event of a potential shortage of opioids, this drug could respond to an unmet need," said Gudin.
Now, with updated safety data, a support committee, and a November 3 PDUFA date, the FDA will have two weeks to decide on the benefits versus the implied risks of Sublingual Sufentanil for the treatment of pain. What can not be lost in this decision are the critical details of its circumstantial use.
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