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NASCOBAL®
(cyanocobalamin) nasal spray

Status: U.S. FDA-Approved, Global Patent through 2023

About Cyanocobalamin Deficiency

A healthy liver stores up to three-years’ worth of cyanocobalamin. However, when the body loses its natural ability to retain cyanocobalamin, such deficiency can persist undetected until the body’s stores are nearly depleted.

Up to 30% of adults develop clinical cyanocobalamin deficiency, with incidence rates climbing much higher for such predisposing conditions as age, certain diseases and invasive medical procedures. Virtually all patients with gastrointestinal afflictions, or who have undergone gastric or intestinal surgery or chemotherapy, are cyanocobalamin deficient. In the U.S. alone, patients receive 39 million cyanocobalamin injections per month.

Cyanocobalamin deficiency must be corrected, and adequate body stores maintained with cyanocobalamin maintenance therapy, to prevent irreversible clinical manifestations. These include, but are not limited to:

• Hematologic
  - Blood: Anemia, leukopenia, thrombocytopenia
  - Smear: Hypersegmentation of polymorphs, macro-ovalocytosis
  - Serum: Elevated lactic dehydrogenase levels, elevated indirect bilirubin levels
  - Bone marrow: Megaloblastic changes, increased iron stores
• Autonomic
  Impotence, urinary or fecal incontinence
• Neuropathic
  Peripheral sensory and motor neuropathy (paresthesias, numbness, cramps, weakness, hypo or hyper reflexia, Rhomberg’s sign), mononeuropathy (optic or olfactory atrophy, light headedness, aphasia), ataxia, spasticity, abnormal gait, combined systems disease, cerebrovascular disease
• Psychiatric
  Dementia, depression, memory loss, lack of concentration, confused state, personality changes, psychosis
• Myelopathic
  Subacute combined degeneration, ataxia, spasticity, and abnormal gait, Babinski’s sign, Lhermitte's sign
• Cardiovascular
  Myocardial infarction, stroke

Prevalent Treatment Options not Optimal

Intramuscular injections can be painful, and are often inconvenient as they must be administered monthly by a medical professional. The substantial length of time between monthly injections also creates peaks and valleys in the patient’s serum cyanocobalamin levels.

With respect to oral treatment options, they tend to suffer from poor bioavailability. Sublingual prescriptions offer less than 1% absorption, and other oral formulations are destroyed by the hostile gastric environment.

Why Nascobal®?

Nascobal® is the only intranasal cyanocobalamin maintenance therapy available.

Intranasal self-administration eliminates both the pain and the inconvenience of intramuscular injection. Self-administration also reduces costs associated with administration by a medical professional. Moreover, the one-puff-per-week dosing maintains smooth, consistent levels of cyanocobalamin at the required therapeutic level, with no peaks and valleys. With respect to sublingual and oral formulations, the intranasal route offers better bioavailability, with 10% absorption.