Nordic Pharma, Inc., a subsidiary of Nordic Group B.V., is partnering with Harrow on the U.S. commercial launch of an authorized generic of Maxitrol (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension).
First: What exactly is an authorized generic?
These forms of generics are prescription-based drugs identical to a brand-name version and sold by the same brand-name manufacturer—but with a different name and labeling on the packaging.
Even further: An authorized generic is basically a generic version of a brand-name drug that is marketed under the original manufacturer’s new drug application (NDA) instead of a separate abbreviated NDA (which is typically required for standard generic drugs).
- A major advantage of this: The authorized generic gives patients essentially the same prescription-based option as a name-brand drug—but for a price that’s far less than its counterpart.
Interesting … and in the case of Maxitrol?
Harrow currently owns the U.S. commercialization rights to Maxitrol (the name-brand drug) and is partnering with Nordic Pharma to bring its authorized generic version to the U.S. market.
Give me some background on this.
Available as both an eye drop and ointment, Maxitrol was originally granted FDA approval in 2007 under the ownership of Alcon, Inc. prior to the company’s 2011 merger with Novartis.
However, its ownership was retained by Novartis when Alcon spun out into its own publicly traded company in 2019.
Fast forward to December 2021: Harrow purchased the U.S. commercialization rights to Maxitrol from Novartis as part of a major deal involving four FDA-approved ophthalmic medications.
- Per this deal: The four products were to be sold, marketed, and distributed through ImprimisRx, Harrow’s wholly owned subsidiary.
- And at the time, Maxitrol was noted as having “wide insurance coverage” and a “long history of success” for its indication.
Talk about this indication.
The prescription-only formulation is indicated for “steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.”
More specifically: This “ocular steroid” is intended to treat inflammatory conditions of the:
- Palpebral and bulbar conjunctiva
- Cornea
- Anterior segment of the globe
- Notably: Where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation
- Chronic anterior uveitis
- Corneal injury from chemical, radiation, or thermal burns
- Penetration of foreign bodies
And its key ingredients?
Neomycin and polymyxin are antibiotic medications typically used for preventing or treating bacterial infections (and often found in topical creams and ointments for minor skin injuries, cuts, and burns to prevent potential infection).
- On the ophthalmic side: They’re often combined and formulated for treating bacterial infections of the eye and eyelids—including conjunctivitis (pink eye).
Similarly: Dexamethasone, a corticosteroid, is utilized for treating swelling, redness, itching, and allergic reactions within the eye.
So what dosing schedule does Maxitrol follow?
When used as an ophthalmic eye drop for both adults and pediatrics (aged 2+), one to two drops should be topically administered into the conjunctival sac(s) on an hourly basis—and tapered to discontinuation as inflammation subsides.
- For mild diseases: The drops can be administered up to four to six times each day.
Any precautions to keep in mind?
The potential for common and serious side effects. For example:
- Common: blurred vision or mild eye irritation; keratitis
- Serious: tunnel vision; eye pain; ocular swelling or redness; eye crusting or drainage
- See here for a more detailed listing
And contraindications?
A few notable, including:
- Hypersensitivity to any of the drop’s ingredients
- Following uncomplicated removal of a corneal foreign body
- Herpes simplex keratitis (dendritic keratitis)
- Vaccina, varicella, or other viral infections of the cornea or conjunctiva
Importantly: The solution should not be used to treat other forms of ocular infections—such as those caused by viruses, fungi, or mycobacteria—and may potentially even worsen them if it is used.
- Plus: Prolonged use could result in glaucoma, with damage to the optic nerve and defects in visual acuity, fields of vision, and posterior subcapsular cataract formation.
So what can we expect from this authorized generic version?
Not the first generic version of Maxitrol, Nordic Pharma’s product will join its expanding portfolio of niche generic formulations as well as specialty products in therapeutic areas such as ophthalmology and rheumatology.
Per Nordic’s Thomas Sammler, vice president of Commercial Operations: “This product is a great addition to our generic portfolio, providing patients another affordable prescription option.”
And where can I find it for my patients?
That’s currently to be determined.
Check back at the Nordic Pharma site for generic product info on the drug (as of April 28, it’s not yet listed)—and reach out to the company with questions on availability.