Market Dynamics and Financial Trajectory for the Drug: KHEDEZLA
Introduction
KHEDEZLA, an extended-release formulation of the serotonin and norepinephrine reuptake inhibitor (SNRI) desvenlafaxine, was approved by the U.S. Food and Drug Administration (FDA) in July 2013 for the treatment of major depressive disorder (MDD). Here, we delve into the market dynamics and financial trajectory of KHEDEZLA, highlighting key aspects of its market presence, competition, and financial performance.
Market Approval and Regulatory Context
KHEDEZLA was approved under the 505(b)(2) new drug application (NDA) pathway, which allows for the approval of a new drug based on the FDA's findings of safety and/or effectiveness for a previously approved drug. This pathway facilitated a quicker entry into the market, leveraging the existing data from Pfizer’s PRISTIQ, another desvenlafaxine formulation[3][5].
Market Entry and Promotion
Pernix Therapeutics Holdings, Inc. signed an agreement with Osmotica Pharmaceuticals Corp to market and sell KHEDEZLA in the United States. Pernix’s team of approximately 90 sales professionals was instrumental in promoting the product to high desvenlafaxine-prescribing physicians. The promotional strategy included synergistic marketing with Pernix’s sleep maintenance product, SILENOR, to enhance its value proposition to target physicians[5].
Competitive Landscape
KHEDEZLA entered a competitive market dominated by branded and generic formulations of desvenlafaxine. PRISTIQ, the original branded formulation by Pfizer, had significant market share and sales, with annual U.S. sales of approximately $614 million as of 2014[5].
Generic Competition
The generic market for desvenlafaxine has been growing, with generic versions capturing a substantial share of the market. For instance, in 2017, the generic version of desvenlafaxine saw its sales share increase to 24.5%, significantly eroding the market share of branded products like PRISTIQ and KHEDEZLA[1].
Brand vs. Generic Sales
Despite the competitive landscape, KHEDEZLA managed to carve out a niche. However, its sales were dwarfed by both the branded and generic versions of desvenlafaxine. For example, in 2017, KHEDEZLA’s sales share was only 0.1%, compared to the generic desvenlafaxine’s 24.5% share[1].
Financial Performance
The financial performance of KHEDEZLA is closely tied to Pernix Therapeutics' overall strategy and market dynamics.
Revenue Contribution
KHEDEZLA was part of Pernix’s portfolio expansion, aimed at driving growth through both organic and inorganic means. The acquisition and marketing of KHEDEZLA contributed to Pernix’s revenue growth, although the exact figures for KHEDEZLA alone are not separately disclosed. Pernix’s total revenue in 2014 was $121.7 million, up 43% from the prior year, with significant contributions from other acquisitions like Treximet® and Zohydro® ER[2].
Profit Sharing Agreement
Pernix and Osmotica Pharmaceuticals Corp had a profit-sharing agreement for KHEDEZLA, which meant that both companies benefited from the sales of the product. This arrangement helped in mitigating some of the financial risks associated with marketing a new product in a competitive market[5].
Challenges and Opportunities
Black Box Warning
KHEDEZLA, like other antidepressants, carries a black box warning regarding the increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults. This warning can impact prescribing decisions and patient adherence, potentially affecting sales[5].
Market Saturation
The antidepressant market, particularly for SNRIs, is highly saturated with both branded and generic options. This saturation makes it challenging for new entrants like KHEDEZLA to gain significant market share without offering substantial differentiation or cost advantages[3].
Synergistic Marketing
The synergistic marketing approach with SILENOR, another product from Pernix, provided an opportunity to leverage the existing sales force and physician relationships. This strategy helped in optimizing the promotional efforts and enhancing the product’s visibility in the market[5].
Key Takeaways
- Regulatory Approval: KHEDEZLA was approved under the 505(b)(2) pathway, leveraging existing safety and efficacy data.
- Market Entry: Promoted by Pernix Therapeutics with a focus on synergistic marketing with SILENOR.
- Competitive Landscape: Faces significant competition from both branded and generic desvenlafaxine formulations.
- Financial Performance: Contributed to Pernix’s revenue growth, though exact figures are not disclosed separately.
- Challenges: Includes a black box warning and market saturation.
- Opportunities: Synergistic marketing with other products in Pernix’s portfolio.
FAQs
Q: What is KHEDEZLA used for?
A: KHEDEZLA is used for the treatment of major depressive disorder (MDD).
Q: How was KHEDEZLA approved by the FDA?
A: KHEDEZLA was approved under the 505(b)(2) new drug application (NDA) pathway, relying on the FDA's findings of safety and/or effectiveness for a previously approved drug.
Q: Who markets and sells KHEDEZLA in the United States?
A: Pernix Therapeutics Holdings, Inc. markets and sells KHEDEZLA in the United States through an agreement with Osmotica Pharmaceuticals Corp.
Q: What is the competitive landscape for KHEDEZLA?
A: KHEDEZLA competes with both branded and generic formulations of desvenlafaxine, including PRISTIQ and generic desvenlafaxine.
Q: Does KHEDEZLA have any specific warnings or contraindications?
A: Yes, KHEDEZLA carries a black box warning regarding the increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults.
Sources
- Global Generic and Biosimilars Trends and Insights - IQVIA MIDAS MAT Q3 2017
- HEALTHY FUTURES - Annual Reports - Pernix Therapeutics Holdings, Inc.
- In Brief: Khedezla - A New Brand of Desvenlafaxine - The Medical Letter
- KHEDEZLA (desvenlafaxine) Extended-release - FDA Label
- Pernix Signs Agreement with Osmotica Pharmaceutical Corp to Promote KHEDEZLA - Business Wire
