Glenmark Pharmaceuticals Ltd. announced it has received FDA approval for an abbreviated new drug application (ANDA) for brimonidine tartrate and timolol maleate ophthalmic solution 0.2%/0.5% to treat glaucoma and ocular hypertension (OHT) patients.
Let’s start with this company.
Headquartered in Mumbai, India, Glenmark Pharmaceuticals is a multinational, research-led pharmaceutical company developing branded, generic, and over-the-counter (OTC) products.
Among its research and development activities is a focus on developing and marketing branded and generic formulations in such therapeutic areas of:
- Respiratory
- Cardiology
- Diabetes
- Oncology
- Anti-infectives
What is its connection to the U.S.?
Since launching its first product in North America in 2005, Glenmark has established its U.S. operations, which includes a distribution center and warehouse, in Mahwah, New Jersey.
The specific focus: generics and OTC.
Gotcha. Now explain what an ANDA is.
An “abbreviated” NDA—not to be confused with a regular new drug application (NDA)—refers to generic drug compounds that are comparable to an already FDA-approved drug product.
The distinct difference: Unlike an NDA, preclinical and clinical data isn’t required in order to establish safety and efficacy of a drug compound.
What’s the approval process like?
The drug must be tested on a small group of patients to evaluate whether it is “bioequivalent.” Meaning: ensuring it can reach the target tissue where it is intended to work at the same time and in the same amount (concentration level) as the brand-name medication.
And to be approved?
The generic drug would need to deliver “the same amount of active ingredients in a patient’s bloodstream in the same amount of time” as the already-approved drug.
The result: This process allows the FDA to approve applications to market generic versions of brand-name drugs without the need for costly clinical trials and, as a result, provide a potentially lower-cost alternative to the commercially available brand-name medication.
Gotcha! So what are these new generics?
The formulations are the generic equivalent to AbbVie Inc.’s (via Allergan, Inc) COMBIGAN ophthalmic solution 0.2/0.5%.
What it is: Originally FDA approved in 2007, COMBIGAN is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor
Its indication: For topical administration to reduce elevated intraocular pressure (IOP) in patients with glaucoma or OHT.
And its dosage?
One drop of the formulation is intended to be administered twice a day (BID) in the affected eyes(s), approximately 12 hours apart.
See here for COMBIGAN’s full prescribing information (PI).
How is the efficacy of this solution vs 0.5% timolol and 0.2% dosed separately?
Not as high, actually.
When dosed BID, the formulation is reported to be “slightly less” than that seen with a concomitant administration of timolol maleate (BID) and 0.2% brimonidine tartrate dosed three times a day (TID).
Any warnings associated with the brand-name version?
Notable warnings and precautions include:
- Potential for severe respiratory or cardiac reactions
- Cardiac failure
- Obstructive pulmonary disease
- Potential for vascular insufficiency
- Increased allergen reactivity
- Potential for muscle weakness
- Masking of hypoglycemic symptoms in diabetes mellitus (DM) patients
- Thyrotoxicosis masking
- Ocular hypersensitivity
And adverse reactions?
A few … the PI noted that, in 12-month clinical trials, an estimated 5% to 15% of participants most frequently experienced the following reactions after use:
- Allergic conjunctivitis
- Conjunctival folliculosis
- Conjunctival hyperemia
- Eye pruritus
- Ocular burning
- Stinging
And among 1% to 5% of patients:
- Asthenia
- Blepharitis
- Corneal erosion
- Depression
See here for the complete list (under “Adverse Reactions”).
What age group is this most appropriate for?
The brand name’s PI dictates that pediatric patients under age 2 should not be administered the drops, as the safety and efficacy has not yet been studied in that age group.
Its primary patient targets: Those aged 2 to 16 years of age.
Gotcha. So what kind of packaging is the bottle available in?
If the generic formulations are anything like COMBIGAN, they’ll be packaged as a solution containing 2 mg/mL brimonidine tartrate and 5 mg/mL timolol (6.8 mg/mL timolol maleate).
Lastly… when will it be available?
No official word yet, so stay tuned for launch info later this year!