Traditional Drug Pipeline Update: April 2022

This monthly pipeline wrap-up provides a review of newly approved traditional drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

See separate article for pipeline information on specialty drugs.

New Drug Information

• Adlarity™ (donepezil transdermal system): The Food and Drug Administration (FDA) approved Corium’s Adlarity (donepezil, transdermal) as a treatment for patients with mild, moderate, or severe dementia of the Alzheimer’s type. Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin, resulting in a low likelihood of adverse gastrointestinal (GI) side effects associated with oral donepezil. Adlarity was approved through the 505(b)(2) pathway using Pfizer’s oral Aricept^® (donepezil) as its reference drug.[1] Donepezil is the most widely prescribed medication for Alzheimer’s treatment available as a once daily tablet or orally disintegrating tablet. Adlarity will launch in early fall with pricing to follow and will be available as a 5mg/day and 10mg/day transdermal patch.
• Hyftor™ (sirolimus topical gel): The FDA approved Hyftor, Nobelpharma’s topical gel treatment for facial angiofibroma associated with tuberous sclerosis complex (TSC) in adults and children 6 years of age and older.[2] TSC is a genetic disorder that causes tumors to form in multiple organs, primarily the brain, eyes, heart, kidneys, skin, and lungs. Hyftor was approved through the 505(b)(2) pathway using Pfizer’s oral Rapamune as its reference drug.[3] In a single, randomized, double-blind, vehicle-controlled phase 3 trial (n=62), Hyftor applied twice daily to affected skin improved the size and redness of facial angiofibromas at 12 weeks compared to vehicle. Approximately 75-80% of TSC patients have facial angiofibromas which may cause disfiguration, bleeding, pruritus and erythema. Approximately 50,000 people have TSC in the US, and an estimated 40,000 have TSC-related facial angiofibroma. Sirolimus is also available generically as oral tablets and solution. Pricing and launch information have not been released.
• Xelstrym™ (dextroamphetamine) transdermal system: Noven received FDA approval for Xelstrym (dextroamphetamine) transdermal system for the treatment of attention-deficit/hyperactivity disorder (ADHD) for adults and pediatric patients 6 years and older. Xelstrym was approved through the 505(b)(2) pathway using Takeda’s oral Vyvanse^® (lisdexamfetamine dimesylate) as its reference drug. One Xelstrym patch should be applied 2 hours before an effect is needed and removed within 9 hours. Xelstrym is the first FDA-approved transdermal amphetamine patch, it is also available as an oral generic.[4] Noven’s Daytrana (methylphenidate) is also a transdermal patch FDA approved for ADHD. Launch of Xelstrym is anticipated in the U.S. in the second half of 2022 with pricing to follow.
• Igalmi™ (dexmedetomidine) sublingual film: BioXcel received FDA approval for Igalmi (dexmedetomidine) in adults for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder.[5] Igalmi can be self-administered but under the supervision of a healthcare provider to monitor vital signs and alertness after administration to prevent falls and syncope. Igalmi was approved through the 505(b)(2) pathway using Pfizer’s intravenous Precedex^® (dexmedetomidine hydrochloride) for sedation induction and sedation maintenance of mechanically ventilated intensive care patients as its reference drug. Data from two double-blind, placebo-controlled, parallel group phase 3 trials (SERENITY I and II) demonstrated that Igalmi met the primary endpoint of achieving statistically significant and clinically meaningful reduction in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) score at 2 hours vs placebo (P<0.0001). Safety and efficacy have not been established beyond 24 hours from the first dose. Igalmi is expected to be available in the second quarter of 2022 with pricing to follow.

Generic Drug Information

• Samsca^® (tolvaptan): Multiple manufacturers launched their generic version of Otsuka America’s Samsca for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium). Samsca generated $76 million in U.S. annual sales in 2021.
• Vimpat (lacosamide) tablets: Multiple manufacturers have launched their generic versions of UCB Pharma’s Vimpat 50, 100, 150, 200 mg tablets with more manufacturers set to follow. Vimpat is indicated for the treatment of partial-onset seizures in patients 1 month of age and older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. Vimpat generated $1.7 billion in U.S. annual sales in 2021.
• Zipsor (diclofenac): Teva and Aurobindo launched their generic versions of Assertio’s Zipsor for relief of mild to moderate acute pain. Zipsor generated $20 million in U.S. annual sales in 2021.

[1] https://www.prnewswire.com/news-releases/corium-receives-fda-approval-of-adlarity-donepezil-transdermal-system-for-treatment-of-patients-with-alzheimers-disease-301501426.html

[2] FDA approves Nobelpharma’s HYFTOR™ (sirolimus topical gel) 0.2% | BioSpace

[3] NDA 213478 Approval 2022XXXX (fda.gov)

[4] PR032322.pdf (noven.com)

[5] Igalmi Sublingual Film Approved for Agitation With Schizophrenia, Bipolar Disorder (empr.com)