Company: MIRA
Filing Date: 2025-08-08
Form Type: DEFM14A
Source: 0001641172-25-022816
Chunk: 187

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-08-08
Form: DEFM14A
Chunk 187
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., 
 patches, gum, lozenges, inhalers, nasal spray).                                               |

| ● | Bupropion:                                                            
 An antidepressant that helps reduce cravings and withdrawal symptoms. |

| ● | Varenicline:                                                                              
 A medication that partially stimulates nicotine receptors, reducing cravings and blocking 
 the rewarding effects of nicotine.                                                        |

| ● | Cytisine:                                                                                   
 A plant-based alkaloid with similar effects to varenicline (not approved in all countries). |

Behavioral Counseling:Provides support, coping strategies, and problem-solving skills to manage cravings and prevent relapse.

Combination Therapy:The most effective approach often involves combining medication with behavioral counseling, which can double or triple a smoker’s chances of successful quitting.

Emerging Treatments:Repetitive transcranial magnetic stimulation (rTMS) has shown promise in reducing nicotine cravings and aiding cessation.

Epidemiology of Nicotine Dependence

Approximately 32% of first-time nicotine users develop dependence 1. Globally, there are an estimated 976 million smokers 2, with roughly half meeting DSM criteria for dependence. While smoking rates and the number of cigarettes smoked per day are declining in some regions, like the United States, certain populations exhibit higher smoking prevalence, including individuals with lower education or socioeconomic status and those with mental illness. Men tend to smoke at higher rates and score higher on dependence indices, although women may face greater difficulty in quitting. Nicotine dependence is also more frequent among individuals with anxiety disorders.

Alarmingly, only about 6% of smokers who attempt to quit each year are successful, highlighting the powerful influence of nicotine dependence. The emergence of e-cigarettes raises concerns about potential new forms of nicotine dependence, particularly among youth 3.

MacDonald, K; Pappa, K (April 2016). “WHY NOT POT? A Review of the Brain-based Risks of Cannabis”. Innov Clin Neurosis

2 Ng, M; Freeman, MK; Fleming, TD; Robinson, M; Dwyer-Lindgren, L; Thomson, B; Wollum, A; Sanman, E; Wulf, S; Lopez, AD; Murray, CJ; Gakidou, E (8 January 2014). “Smoking prevalence and cigarette consumption in 187 countries, 1980-2012”

3 Rachid, Fady (2016). “Neurostimulation techniques in the treatment of nicotine dependence: A review”. The American Journal on Addictions