Bupropion + dextromethorphan

Unassigned

New Medicines

Treatment-resistant depressive disorder

Information

New formulation
Not Known
Axsome Therapeutics

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Fixed-dose combination of bupropion (inhibitor of norepinephrine and dopamine uptake & a nicotinic acetylocholine receptor antagonist) plus dextromethorphan (non-competitive NMDA receptor antagonist, & a sigma-1 receptor agonist).
Data from 298 UK general practices showed that the incidence of diagnosed depression fell from 22.5 to 14.0 per 1,000 person-years at risk from 1996 to 2006. The incidence of depressive symptoms, however, rose threefold from 5.1 to 15.5 per 1,000 person-years at risk. The total incidence adding these two incidences together remained unchanged, suggesting that there was a trend for GPs to document symptoms rather than formal diagnoses [1].
Treatment-resistant depressive disorder
Oral

Alzheimer's disease-associated agitation

Information

Licence extension / variation
Not Known
Axsome Therapeutics

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Fixed-dose combination of bupropion (inhibitor of norepinephrine and dopamine uptake & a nicotinic acetylocholine receptor antagonist) plus dextromethorphan (non-competitive NMDA receptor antagonist, & a sigma-1 receptor agonist).
Alzheimers disease is the most common form of dementia, accounting for around 50% of cases. It is estimated to affect 496,000 people in the UK. In the later stages, symptoms include agitation [1].
Alzheimer's disease-associated agitation
Oral

Moderate to severe major depressive disorder (MDD)

Information

Licence extension / variation
Not Known
Axsome Therapeutics

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Fixed-dose combination of bupropion (inhibitor of norepinephrine and dopamine uptake & a nicotinic acetylocholine receptor antagonist) plus dextromethorphan (non-competitive NMDA receptor antagonist, & a sigma-1 receptor agonist).
In the UK, the prevalence of major depressive disorder is estimated to be between 5% and 10% of people seen in primary care and 10% to 14% of medical inpatients, although it may be underdiagnosed. Between 10% and 15% of older people have symptoms of depression. The risk of relapse is 50%, 70%, and 90% after the first, second, and third episodes of major depressive disorder respectively. The rate of major depressive disorder in women is twice as high as in men. [1]
Moderate to severe major depressive disorder (MDD)
Oral