On Tuesday, NASDAQ-listed Company Alkermes announced that it had received a letter from the U.S. Food and Drug Administration (FDA) on its new drug, APKS 3831 (Ao nitrogenpine/samidorphan), for adults with schizophrenia and bisomethic type I disorders.
the current psychopathic diseases mainly drug treatment, from the global pharmaceutical market, psycho-neurologic drugs after cardiovascular drugs, has become the world's second largest drug use.
is the ace drug for treating schizophrenia, especially in incurable patients, but long-term medication can easily lead to obesity.
ALKS 3831 is a compound preparation developed for obesity caused by oestration, the active ingredients are O nitrogen flat and samidorphan, both structured as shown in the figure below.
APKS 3831 significantly reduces weight gain caused by taking oxycodm and significantly lowers cholesterol levels and blood pressure.
Ao Nitrogen Ping (OLZ) and APKS 3831 (OLZ/SAM) weight gain waist circumference, blood sugar, total cholesterol, blood pressure data show that in 2019, China's public medical institutions terminal O nitrogen flat sales of more than 4 billion yuan, of which Jiangsu Haussen Pharmaceuticals market share ranked first, reaching 63.9%, Haussen 2019 O nitrogen flat sales of about 2.5 billion yuan.
the U.S. market for about 7 million prescriptions in 2019, ranking fourth.
the top three drugs were pyridoquine, alequinol, and lisperone, all of which belonged to the second generation of antipsychotic drugs.
has a huge market base, the future listing of APKS3831, relying on better results and fewer side effects, will grab considerable sales, APKS 3831 peak annual sales forecast to reach $400 million.
, the FDA issues a Complete Response Letter speaking, indicating that the new drug application data submitted has been reviewed by FDA officials, but the new drug is still pending approval for use.
Alkermes announcement noted that the Company Response Letter received this time did not indicate or raise any concerns about clinical or non-clinical data in new drug applications, nor did the FDA require Alkermes to complete any new clinical trials to support new drug listing applications.
October 9, the FDA's Advisory Committee on Psychopentrides and the Advisory Committee on Drug Safety and Risk Management jointly voted that the committee's doubts about ACKS 3831 were that the opioid-retagonist samidorphan contained in APKS 3831 could cause problems: 1. Patients taking opioids who take APKS 3831 by mistake will develop opioid withdrawal symptoms; 2. Patients taking APKS 3831 may have painkillers when they need opioid painkillers; and 3. Opioid overdoses.
Alkermes offers solutions: 1. In the "Taboos, Warnings and Precautions, Medication Guidelines", APKS3831 is prohibited for those taking opioids; The Warnings and Precautions, Medication Guidelines indicate that patients who have previously taken opioids may become more dependent on opioids after treatment with APKS 3831, and explain to patients who have taken opioids the serious consequences of blocking opioids.
final results: Samidorphan meaningfully reduced the weight gain associated with on-nitrogen drugs (16 yes, 1 no), while the safety of APKS 3831 was fully demonstrated (13 yes, 3 no, 1 abstention).
paved the way for the APKS 3831 to go public.
addition, this CompleteResponse Letter does not raise any clinical questions, indicating that the potentially heavy drug OxyControl compound APKS 3831 is within reach of approval.
While the FDA did not raise any clinical questions about APKS 3831 in this Componse Letter, it will take some time for Alkermes to improve the APKS 3831 package process before it can be approved and responded to by the FDA.
addition, ALKS3831 will not be available until the first quarter of 2021 at the earliest because Samidorphan is an opioid-receiving antagonist that requires U.S. Drug Enforcement Administration (DEA) regulation.