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    Home > Medical News > Medical World News > The FDA has rejected applications for new drugs for tramadol intravenously because of safety.

    The FDA has rejected applications for new drugs for tramadol intravenously because of safety.

    • Last Update: 2020-10-23
    • Source: Internet
    • Author: User
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    The FDA recently announced that it had rejected Avenue Therapeutics' new drug application (NDA) for IV Tramadol for safety reasons.
    the news, Avenue's share price plunged more than 56 per cent in pre-market trading.
    October 12, Avenue released the full FDA Response Letter (CRL) on Qumado intravenous injections.
    The FDA decided not to approve the drug's current form of market application, even though the key Phase 3 clinical trial of the quemado intravenous drug proved that it reached all major and multiple secondary endpoints, showing statistically significant results.
    CRL noted that the use of travamen to treat patients with acute pain who need opioids has raised concerns in the medical community about the potential for patients to actually use opioids to treat pain, which is unsafe for the intended patient population.
    In particular, if a patient needs to use analgesic between the first intravenous quarry and the onion of analgesic treatment, a resuscitative analgesic is required, and the possible option would be another opioid, which would lead to a "stacking" of opioids and increase the likelihood of opioid-related adverse reactions.
    addition to this potential safety risk, the FDA did not find more information about drug safety in Avenue's clinical development program.
    cril said the FDA required the company to conduct adequate end sterilization verification before NDA approval, a requirement scheduled for later in the quarter.
    but Lucy Lu, Avenue's president and chief executive, apparently did not agree with the FDA's questions.
    our extensive clinical database strongly supports the value of intravenous travador as an effective alternative to intravenous Table II conventional opioids," Lu said in a statement.
    , the company supports the ultimate acceptability of security data and varicose veins submitted under nondisclosure agreements.
    will ask to meet with the FDA as soon as possible to work closely to resolve these issues in order to bring this important drug to patients and clinicians in the United States.
    " Avenue submitted an NDA for intravenous quemado to the FDA in December, based on positive results from two key Phase 3 studies and an open-label safety study for patients receiving the intravenous quemado 50 mg dosing program (more than 500 cases).
    One of them reached its primary endpoint, a Phase 3 clinical trial of intravenous quemado for patients with moderate to severe postoperative pain after cystic surgery showed a statistically significant improvement in the amount of pain intensity difference (SPID48) in patients receiving intravenous quemado within 48 hours compared to placebo.
    , the Phase 3 trial also showed that varicose modo had good tolerance and was able to induce pain relief after surgery quickly and effectively.
    addition, the drug's NDA includes an epidemiological study of the abuse of quemado in the United States and some European countries, which already have intravenous quemado.
    study found that there were few reports of quemado abuse, which is less common by injection than oral quemado in countries where qumado products are already available, both in absolute terms and in relation to other prescription opioids.
    Avenue believes that Tramador's intravenous preparations can fill the gap between intravenous acetaminophen/nonsteroidal anti-inflammatory drugs and intravenous conventional anesthetics.
    At the same time, it is hoped that the intravenous dosage form will serve as a bridge to the broad market for oral quemado, and that the combination of oral drugs used after receiving intravenous quemado may replace the recommendation of anesthetics in schedule II of the current standard of diagnosis and treatment in the future.
    source: 1. Avenue Therapeutics Plunges as FDA Rejects NDA for IV Tramadol2. Avenues Receives Complete Response Letter from the FDA for IV Tramadol Management to Host Conference Call at 8:30 a.m. ET3. Avenue Therapeutics' IV Tramadol Show Stellar Data in Phase III.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

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