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Also known as IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin, IFF flavor 316 282, Paracetamol, Pseudoephedrine
IFF flavor 316 282, Paracetamol, Phenylephrine, Guaifenesin · 2 trials · 1 indication
Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0 = no warming sensation and 100 = strongest possible warming sensation
Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation
| Arm | Type | Description |
|---|---|---|
| Upper Respiratory Infections | EXPERIMENTAL | - |
| Upper Respiratory Tract Infection | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| IFF flavor 316 282, Paracetamol, Pseudoephedrine | DRUG | Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine |
| IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin | DRUG | Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup |
Inclusion Criteria: * Subject must have one or more symptoms per category (see also screening assessment of cold symptoms, section 6.1): * mild to moderate body pain, headache, fever or sore throat * nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing Exclusion Crit...
IFF flavor 316 282, Paracetamol, Phenylephrine, Guaifenesin is an investigational combination product being developed by Novartis AG for upper respiratory infections. It combines paracetamol, phenylephrine, and guaifenesin with a flavoring agent. The product is in Phase 3 clinical development.
It is being developed for the treatment of upper respiratory infections. The Phase 3 trials evaluated the warming sensation intensity, flavor acceptability, and local tolerability of the syrup in patients suffering from an upper respiratory tract infection.
Novartis AG (ticker: NVS) is the developer of IFF flavor 316 282, Paracetamol, Phenylephrine, Guaifenesin.
IFF flavor 316 282, Paracetamol, Phenylephrine, Guaifenesin is in Phase 3 clinical development. It is investigational and has not been approved by the FDA.
Two completed Phase 3 trials have evaluated this combination: NCT01586962 and NCT01576809. Both were conducted in Canada in patients with upper respiratory infections. NCT01586962 enrolled 56 patients, and NCT01576809 enrolled 51 patients.
They are related but distinct combination products. IFF flavor 316 282, Paracetamol, Phenylephrine, Guaifenesin contains phenylephrine and guaifenesin, while IFF flavor 316 282, Paracetamol, Pseudoephedrine contains pseudoephedrine instead. Both are being developed by Novartis for upper respiratory infections.