Drug Maker Unveils Experimental Drug as Opioid Alternative

Vertex Pharmaceuticals unveiled VX-548, which showed positive results in three trials as developers continue to demonstrate its efficacy.
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A pharmaceutical company unveiled an experimental new drug that is being touted as a less dangerous alternative to opioids. To date, few drugs have demonstrated enough power to manage higher levels of pain often associated with post-surgery recovery. Research, such as findings in Treatments for Acute Pain: A Systematic Review by Chou R, Wagner J, Ahmed AY, et al. (2022), has shown opioids don’t always work in certain situations.

WXYZ Detroit, an ABC affiliate, reports that Vertex Pharmaceuticals said Tuesday the drug’s use in late-stage clinical trials resulted in “clinically meaningful reduction in pain,” without many of the risks associated with opioids. The new drug is called VX-548 and it’s showing promise in early stages.

Two trials demonstrated that patients who recently came out of surgery who received Vertex’s new drug had statistically significant pain relief. Phase 2 trial results were published Dec. 13, 2023, noting its effects on painful diabetic peripheral neuropathy. Researchers in a third trial observed a wider range of pain-related conditions. Phase 3 trial results were published on Jan. 30, 2024 and showed “clinically meaningful reduction in pain from baseline in both the abdominoplasty and bunionectomy randomized controlled trials,” as well as many other surgery-related conditions. 

Participants who used the drug for up to 14 days also noted positive results, with over 83% of patients saying VX-548 was “good” to “excellent” at managing pain.  

Vertex noted VX-548 was “safe and well-tolerated in all three studies,” but it failed to work better than hydrocodone bitartrate/acetaminophen, aka Vicodin.

Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) by mid-2024 regarding VX-548’s treatment of moderate-to-severe acute pain. Vertex’s Phase 1-3 trials move the company closer to gaining approvals from the FDA. If they are successful, it could  provide people in the U.S. with another pain treatment option.

Opioids Main Driver of U.S. Drug Overdoses

The vast majority of drug overdoses in the U.S. continues to be dominated by opioids. And to make things worse, the confusion over addiction leads to making it harder for patients who actually need opioids to get them prescribed.

According to The National Center for Health Statistics (NCHS) under the U.S. Centers for Disease Control and Prevention, drug overdose deaths rose from 2019 to 2021 with over 106,000 drug overdose deaths reported in 2021. Deaths involving synthetic opioids—primarily fentanyl and excluding methadone—continued its death march with 70,601 overdose deaths reported in 2021. Fentanyl in particular kills 150 Americans per day.

Many other attempts to develop alternatives to opioids that effectively dull pain, but they typically fail. If Vertex’s drug is ultimately deemed to be safe, it could introduce a new class of acute pain medicine for the first time in about 20 years, Dr. Jessica Oswald told WXYZ.

“As a physician treating patients suffering from pain for many years, I know firsthand the critical need for new, efficacious and safe treatment options,” Oswald said. “The Phase 3 safety and efficacy across the three studies are impressive and demonstrate VX-548’s potential to change the paradigm of pain management.”

Opioids kill more Americans than car crashes or gun violence. An alternative to effective, but highly dangerous opioids, some of which having the power to stop breathing, is sorely needed.

History of Opioid Alternatives

Bayer introduced heroin in 1898 and called it a “wonder drug” meant to be less addictive than morphine, which was ravaging America at the time with drug addicts. It wasn’t until over 10 years later that an army of heroin addicts emerged.

Cannabis itself has been explored as an opioid alternative, but it works in very different ways. One study is taking a closer look at the specific holistic effects that both medical cannabis and opioids provide to get more insight on the efficacy of each substance as it pertains to chronic pain management.

The recent study, “The holistic effects of medical cannabis compared to opioids on pain experience in Finnish patients with chronic pain,” was conducted by a team of researchers from Åbo Akademi University, who looked into the effects of medical cannabis and opioids for chronic pain treatment.

Published in the Journal of Cannabis Research, the study aimed to take a closer look at how effective medical cannabis is compared to traditional opioids in treating chronic pain, as cannabis use for symptom management has become increasingly more common in recent years. Results suggested that opioids and cannabis are both “equally efficacious” at mitigating pain intensity in patients with chronic pain, while cannabis offered more “holistic” relief in improving sleep, focus and emotional wellbeing.

Vertex Pharmaceuticals could help provide a safer alternative compared to typical opioids that have created an epidemic of drug overdoses in the U.S.

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  1. The vast majority of true opioid ‘overdoses’ (where someone dies from an excessively large dose) are not intentional and are therefore a product of prohibition which creates an environment where regular users of drugs do not have a reliably regular supply of their drug of choice – this means their tolerance is constantly changing, while their psychological addiction (the important one) remains; a logical recipe for disaster if you think about it.
    Worse still is an almost complete lack of quality harm-reduction/education, meaning people take cues from (copy) appallingly dangerous fictional representations eg. Nurse Jackie crushing Oxycodone pills and snorting them, which literally kills people via Talcosis of the lungs (COPD caused by inhaling Talc powder, which is a pill component).
    Likewise persistent myths about opioids don’t help either eg. Heroin (aka diacetylmorphine) is more dangerous and more addictive than Morphine. Numerous published clinical trials in both addicts and non-addicts has disproven this and in fact some opioid addicts prefer Morphine to Heroin (when given them in pure form).
    In fact Heroin is actually SAFER than Morphine in some ways because it induces slightly less histamine release (Histamine release by morphine and diamorphine in man – Anaesthesia, 1993, Volume 48, pages 26-29) and produces a lesser drop in blood pressure with an equivalent analgesic dose.
    Likewise statements such as “…over 10 years later (after 1898) that an army of heroin addicts emerged.” are simply not true and a thorough analysis of the best statistics available from that time does not show that. In fact numerous excellent such analyses have been published and are worth quoting here:

    From Heroin in the Treatment of Morphine Addiction – Journal of Psychoactive Drugs Vol. 9(No. 3)193-197 1977

    “The French critics of heroin substitution (for morphine) based their arguments on the presumption (erroneous in the light of current knowledge) that heroin was more toxic and caused a more persistent addiction than morphine, and on their assumptions, unsubstantiated, and perhaps even contradicted by the text of their articles, that heroin addiction was becoming very widespread.”
    &
    “How extensive was heroin addiction in the United States? The Florida Board of Ilealth reported that in 1912 heroin users co nstitu ted 6.41 % of the addicted population, 22 of 343 opiate users. In 1913 the percentage was slightly less, 5.18% and in 1914, 5.27% (Terry & Pellens, p. 85) But it was New York City that was reputed to be the center of heroin use. Still, data on admission to Bellevue Hospital between 1905 and 1916 reveal th at while there were few admissions for morphine addiction between 1905 and 1909, there were none at all for heroin addiction. From 1910 on, the number of admissions increased in both categories, but heroin addict admissions remained far fewer than morphine addict admissions until 1915, the year that the Harrison Narcotic Act became effective and 13 years after the concept of heroin substitution had last been advocated in print. Similar findings were reported from Philadelphia General Hospital between 1911 and the early part of 1915. It appears, in fact, that heroin addiction was uncommon until after 1910 and did not constitute an important portion of the opiate problem until several years later.”
    &
    “If any blame is to be accorded for the rising popularity of heroin among addicts, it can be attributed to the new laws controlling opiate dispensing. Terry and Pellcns wrote:
    With the enforcement of these laws and the consequent restrictions placed on physicians, druggists and manufacturers of pharmaceutical preparations, and illicit traffic hitherto sporadic became general and well organized. Heroin particularly was adopted to the purposes of vendors of illicit drugs. inasmuch as its morphology permitted easily of aduIteration with sugar or milk or certain coal-tar products while morphine could be so treated only with difficulty. (Terry & Pellens 1928, pp. 85-86)
    In short, heroin became a widely used drug among addicts because it was readily available from the illicit market while other opiates were not. The outbreak of adolescent heroin addiction in New York in the years preceding World War I can best be explained bv the presence of a black market in it. That source, while originally developed in response to the demand of morphine addicts for narcotics of any nature once legitimate sources dried up, became the supplier to youths who were at first merely seeking adventure but who later became regular customers.”

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