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    Subcutaneous implantation of naltrexone: a new therapy for opiate use disorder
    Click:136  Update time:2022-12-02  【Close

    In September 2022, BioCorRx (OTC: BICX) announced the BICX104 plan The last patient in Phase I clinical trial was enrolled. BICX104 implant. It is a subcutaneous implant containing the active ingredient naltrexone. Now naltrexone has been approved for the treatment of opiate use disorders.


    (Source: Network)


    Overview of Opioid Use Disorders

    Opioids are used in medicine to relieve pain, have analgesic and central nervous system inhibitory effects, and may also cause euphoria. Opioid use disorder (OUD) includes improper use of prescription opioids, use of opioids as drugs, or use of illegally obtained heroin. OUD is usually a chronic and recurrent disease, which can lead to a significant increase in the incidence of complications and mortality.


    OUD Epidemiology

    Since the 1990s, the incidence of OUD and opioid overdose related deaths has been increasing, reaching epidemic scale [2]. Illicit access to and prescription use of opiates have increased:


    ---In 2019, it is estimated that 5.7 million people (2.1% of people ≥ 12 years old) in the United States used heroin; 431000 people (0.2%) reported using heroin last month [3]. Between 2002 and 2018, the incidence of heroin use and heroin use disorders nearly doubled.


    ---In the United States, the use of illegal synthetic opiates such as fentanyl has also increased. The number of deaths caused by the use of these synthetic opioids (excluding methadone) increased, and the age adjusted incidence rate increased from 9.0% (28466 deaths) in 2017 to 9.9% (31335 deaths) in 2018.


    ---In 2015, 3.8 million individuals aged 12 and above in the United States reported improper use of prescription painkillers in the past month [7]. Among them, 2 million people have been dependent on OUD or opioids that meet the definition of DSM-IV in the past year.


    OUD drug treatment

    The drug treatment of OUD includes the use of opioid receptor agonists or antagonists, which is the first-line treatment for most patients with OUD, including buprenorphine, naltrexone and methadone. Buprenorphine and methadone are opioid receptor agonists, and naltrexone is opioid receptor antagonists. It is generally believed that OUD is a chronic disease requiring long-term treatment. In addition, long-term treatment can strengthen abstinence and improve maintenance treatment rate.

    Market of naltrexone

    There are two kinds of dosage forms of naltrexone, oral and injection. In 1984, naltrexone was approved by FDA for the first time. The dosage form is a tablet for the treatment of OUD. In 1994, the indication was added and it was approved for the use of alcohol disorder AUD. In 2010, the long-acting muscle injection type (once a month) developed by ALKERMES was approved for marketing.

    Sales in US

    Sale Value(USD100mn) 2017 2018 2019 2020 2021
    Vivitrol 3.92 4.43 4.52 3.64 4.47
    Other 0.20 0.22 0.25 0.29 0.36
    Total 4.12 4.65 4.77 3.93 4.82
    Sale Share 2017 2018 2019 2020 2021
    Vivitrol 95% 95% 95% 93% 93%
    Other 5% 5% 5% 7% 7%
    Total 100% 100% 100% 100% 100%

    BioCorRx is located in Anaheim, southern California (where California Disneyland was built). The company focuses on drug addiction and alcohol addiction, and is committed to developing new therapies with more advantages. The drug delivery technology of BICX104 plant is from Calista Therapeutics, and BioCorRx acquired the patent technology of Calista through acquisition. The patent US2021/0393516 was submitted to the United States Patent Office in 2021.

    (來源:網絡)


    According to the patent documents, the implant delivery system includes three parts: 1) the outermost layer containing biodegradable materials; 2) Primary Core containing active ingredients; 3) Sending Core: It contains signal markers, enabling remote monitoring of drug release status of implants.

    (Source: Network)


    In addition, compared with Vivitrol, BICX104 is a long-acting dosage form that is injected once a month, and can be released for 3 months. According to the development plan disclosed by the company, BICX104 plan It is planned to develop the path according to 505 (b) (2), and at the pre IND meeting with FDA, FDA agreed to conduct only Phase 1 clinical trial, without the need for subsequent Phase 2 and Phase 3 clinical trials, and can use the previous safety and effectiveness data to replace the support to apply for listing.


    Phase I clinical trial design of open label
    Enrollments Interventional Primary Outcome Measures
    24

    BICX104:

    containing 1g naltrexone;

    Iadministered once for 84 days.

    Cmax. [ Time Frame: 140 Days ]

    Tmax. [ Time Frame: 140 Days ]

    AUC [ Time Frame: 140 Days ]

    Vivitrol:

    containing 380 mg of naltrexone;

    administered once every 28 days for 84 days.

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