Buerger’s Disease and Critical Limb Ischemia are distinct types of severe peripheral arterial disease (PAD). Smokers with these advanced stage disorders have typically exhausted all other treatment options and have an immediate medical need to stop smoking in order to limit further tissue damage produced by nicotine and reduce disease symptoms. Clinical symptoms in smokers with these types of severe PAD consist of moderate to severe pain upon walking and/or at rest, and skin ulcers in their limbs that do not readily heal. In the most severe cases, gangrene develops in the hands, feet, or extremities often leading to partial or full limb amputation. In addition, some patients are often debilitated due to their inability to walk and may experience excruciating pain.
While difficult for non-smokers to comprehend, the addictive power of nicotine is so strong that even facing these dire outcomes, nearly half of those with severe PAD still fail to stop smoking. These patients should not use Nicotine Replacement Therapy (NRT) as an aid in smoking cessation, because chronic NRT dosing provides continued exposure to nicotine. Buerger’s disease is a serious medical condition requiring new treatment approaches, and as an orphan disease, it should support accelerated development and market availability.