Pfizer Announces Top-Line Data from Phase IV Clinical Study of Veterinary Groups

Pfizer Announces Top-Line Data from Phase IV Clinical Study of Veterinary Groups

March 27, 2018 Source: Sina Pharmaceutical

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US pharmaceutical giant Perry (Prizer) recently released top-line data from a Phase IV clinical study of the smoking cessation drug Chantix/Champix (varenicline).

The study was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose-ranging study conducted in 312 healthy adolescents aged 12-19 years with nicotine dependence and assessed the combination of varenicline and age. Counseling for the efficacy and safety of smoking cessation. The teenagers enrolled in the study smoked at least 5 cigarettes a day, had a willingness to quit, and had failed at least once before attempting to quit. In the study, patients were divided into 2 cohorts according to body weight (≤ 55 kg, > 55 kg). After 2 weeks of drip, patients randomized to varenicline received different doses depending on body weight: patients weighing >55 kg received 1 mg twice daily (high dose group) or twice daily 0.5 mg (low In the dose group, patients weighing ≤ 55 kg received 0.5 mg twice daily (high dose group) or 0.5 mg once daily (low dose group). In the study, patients were treated for 12 weeks, followed by a 40-week non-treatment follow-up period.

The data showed that the study did not reach the primary endpoint, and there was no statistically significant difference in varenicline versus placebo in terms of the 4-week consecutive cessation rate for the 9-12 week treatment. In terms of safety, the adverse events observed in this study for varenicline in adolescent smokers were similar to those in adult studies. The most common adverse reactions (incidence rate ≥ 5%), high-dose group including nausea, headache, vomiting, agitation, abnormal dreams; low-dose group including nausea, dizziness, agitation, abnormal dreaming, upper respiratory tract infection.

The full results of the study will be announced at a future scientific conference. As part of regulatory regulation in the United States and the European Union, these data will be submitted to the FDA and EMA for the decision to use the Varenialine Pediatric Indications. Details of the study can be found at https:// (Clinical Trial ID: NCT01312909).

It is worth mentioning that the study is a post-marketing study conducted in response to regulatory requirements in the United States and the European Union, targeting the US 12-16 year old, EU 12-17 year old youth smoking group. Dr. James Rusnak, Principal Development Director of Pfizer Medical, said the study provides a valuable contribution to the development of limited clinical studies on drug smoking for drug smoking cessation in adolescent smoking groups. Varenican is an important treatment option for adults aged 18 and over who want to quit smoking.

Chantix (brand name Champix in the European Union and other countries, Chinese brand name: "Changpei") was approved by the US FDA in May 2006 as a prescription drug, combined with counseling, to help people with the willingness to quit smoking 18 years old And above the adult group for drug smoking cessation. To date, varenicline has been approved by more than 100 countries for adult smoking groups aged 18 and over, and as many as 24 million people worldwide have received varenicline treatment. This medicine is used to treat nicotine addiction, can effectively alleviate the craving and withdrawal symptoms of nicotine, and can help reduce the pleasure of smoking cigarettes and other tobacco products during 12 weeks of treatment.

Chantix is ​​capable of selectively and highly affinity binding to the α4β2 neuronal nicotinic acetylcholine receptor. The drug cessation effect is considered to be the result of varenicline against the α4β2 subtype nicotinic receptor: binding to the receptor produces agonism, while blocking the binding of nicotine to these receptors, which is the role of varenicline in smoking cessation. mechanism.

In vitro electrophysiological studies and in vivo neurochemical studies have shown that varenicline binds to the α4β2 neuronal nicotinic acetylcholine receptor and activates receptor-mediated activity, but this effect is significantly weaker than nicotine. Varenicline blocks the binding of nicotine to the α4β2 nicotinic acetylcholine receptor to activate the central nervous system brain dopamine system (MLDS), which is considered to be a potential neural mechanism for smoking intensive-rewarding. The highly selective binding of varenicline to the α4β2 nicotinic acetylcholine receptor is significantly stronger than that of other common nicotinic receptors (>500-fold [α3β4], >3500-fold [α7], >20,000-fold [α1βγδ]) And non-nicotinic receptors and transporters (>2000 times). In addition, varenicline and serotonin (5-HT3) receptors also have moderate affinities (Ki = 350 nM). (Sina Pharmaceutical Compilation/newborn)

Article reference source:

1. PFIZER REPORTS TOP-LINE RESULTS FROM A STUDY OF CHANTIX®/CHAMPIX® (VARENICLINE) IN ADOLESCENT SMOKERS

2, CHANTIX label information and medication guidance

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