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What is Pleconaril
Pleconaril (formerly known as VP-63843) is an oral antiviral agent active against a broad spectrum of picornaviruses.
Within the genus of Picornaviridae are the enteroviridae (with 71 serotypes) and rhinoviridae (with > 100 serotypes).
Rhinoviruses lead to the common cold, most common in the fall and spring, and have been implicated in acute otitis media, acute sinusitis, and chronic exacerbations of chronic obstructive pulmonary disease (COPD) and asthma.
Enteroviruses are responsible for typically self-limiting diseases such as viral upper respiratory tract infections; however, some enterovirus may lead to serious or life-threatening infections in susceptible populations.
Pivotal clinical trials evaluating pleconaril are unpublished. Initial clinical success has been demonstrated in a host of life-threatening enteroviral infections.
The use pleconaril for treatment of the common cold is controversial, as any drug used for a widespread, non-lethal condition must prove to be safe, efficacious and cost-effective.
The safety profile of pleconaril in neonates through adults appears to be excellent, with predominantly mild GI and CNS complaints.
Future clinical trials will focus on pediatric indications such as otitis media, neonatal enteroviral sepsis or in high-risk patients with COPD or asthma.
Currently, no therapy is FDA-approved for treatment of enteroviruses or rhinoviruses.
Pleconaril was previously available for compassionate-use to treat life-threatening enteroviral infections (ViroPharma); however, this program has been discontinued.
The pleconaril NDA for the treatment of the common cold was deemed ‘not-approvable’ in May 2002 by the FDA because adequate safety had not been demonstrated.
In November 2003, ViroPharma licensed pleconaril to Schering-Plough. An intranasal formulation of pleconaril is currently in Phase II clinical trials for management of the common cold and asthma exacerbations.
Indications
- acute flaccid paralysis
- common cold
- encephalitis
- enterovirus
- enterovirus infection
- meningitis
- myocarditis
- poliovirus
- poliovirus infection
- rhinovirus
- rhinovirus infection
- sepsis
- upper respiratory tract infections
Side Effects
- abdominal pain
- anorexia
- ataxia
- crystalluria
- diarrhea
- dysgeusia
- dyspepsia
- fatigue
- headache
- increased urinary frequency
- nausea
- syncope
- vomiting
- weakness
Monitoring Parameters
- urinalysis
Contraindications
- breast-feeding
- dehydration
- driving or operating machinery
- hepatic disease
- hepatitis
- neonates
- nephrolithiasis
- oliguria
- pregnancy
- renal disease
- renal failure
- renal impairment
Interactions
No information is available regarding drug interactions associated with Pleconari
