September 29, 2020 PAP-Q3-20-CL-007
Avara Pharmaceutical Services was established in 2015 and has a network of well-established facilities with proven track records and capabilities across OSD and sterile manufacturing and packaging services. Our mission is to consistently provide responsive, flexible, and tailored contract manufacturing services to pharmaceutical innovators and drug developers of all sizes and enable them to quickly and efficiently bring quality products to patients. We offer a flexible, responsive, client-centric approach and function as a true partner to our pharma clients as they strive to deliver life-changing medicines to the people who need them.
OSD manufacturing is a core Avara capability. We manufacture standard, potent, and controlled substance prescription (Rx) therapies and OTC products across three OSD sites acquired from well-respected pharmaceutical companies. All Avara projects are completed in facilities with proven track records of regulatory compliance and reliable delivery of large-scale commercial supplies.
The Avara Aiken facility, located in South Carolina, has been a part of the Avara family since 2018. At this site, there is over 40 years of experience in secondary manufacturing and integrated packaging of Rx and OTC tablets, capsules, and lozenges. Avara Aiken offers blending, hot melt technology, granulation, compression, coating, encapsulation, customized packaging services, and more. Operating under Avara’s global Quality Management System (QMS) framework, it has received regulatory approvals from agencies including the U.S. FDA, EMA, GCC and ANVISA.
Many Rx-to-OTC switches have been successfully completed at the Aiken site. Transfer of a prescription drug to OTC status is a highly regulated process. Only Rx drugs that have proven to be safe and effective and easy for consumers to correctly self-administer can be converted to OTC products.
According to the Consumer Healthcare Products Association, over 700 products have been approved to switch from Rx to OTC since 1976.1 In addition to increasing access to medicines, Rx-to-OTC switches help drive down overall healthcare costs.1 A study by researchers at Northwestern University revealed that the use of OTC products to treat respiratory infections could save $4.75 billion annually. OTC medicines are in particular cost-effective for people without health insurance. The Rx-to-OTC switch also often increases sales of older Rx products. Sales of nicotine replacement therapies, for instance, doubled the first year they were available as OTC products.2
The U.S FDA’s Nonprescription Drug Safe Use Regulatory Expansion (NSURE) initiative, launched in 2012, has widened the potential classes of drugs that can undergo the Rx-to-OTC switch. Some well-known drugs that have undergone Rx-to-OTC conversions in the last decade include Advil, Allegra, Nasacort, Nexium, Flonase, and Xyzal.3 By mid-February 2020, the FDA had approved three additional Rx-to-OTC switches: one for arthritis pain and two for redness of the eyes and itching due to allergies.4
Successful Rx-to-OTC conversions require knowledge of the regulatory process for their approval, a thorough understanding of the prescription drugs being considered for the conversion process, and knowledge of how to translate prescription labels into consumer-friendly directions. Selecting the best approach for achieving any particular Rx-to-OTC switch is also important, as the FDA has outlined various options for making more prescription drugs available as OTC products.4
Establishing the right strategy for the development of an OTC version of an Rx drug is, therefore, essential. Working with an outsourcing partner that has extensive experience in completing multiple Rx-to-OTC conversions is the best way to ensure that the right approach is taken, and the development process is tailored to the specific prescription therapy in question. The experts at Avara’s Aiken facility have the experience to help streamline the process and reduce the time needed to achieve successful Rx-to-OTC conversions.
“FAQs About Rx-to-OTC Switch.” Consumer Healthcare Products Association. 2020. Web.
Jaap, Charles. “Rx-to-OTC Switches Represent Huge Market Potential.” Pharmaceutical Development Group. n.d. Web.
Saleh, Naveed. “From Rx-to-OTC: 13 drugs that made the switch in the past decade.” MDLinx. 9 Jan. 2020. Web.
Brennan, Zachary. “Rx-to-OTC Switches: FDA Signs Off on Three Drugs.” RAPS. 17 Feb. 2020. Web.
Patrick Hatem has over 27 years of industry experience at CDMOs and specialty pharmaceutical companies. Through his experience, he has established a strong foundation of development, analytical, quality/regulatory, manufacturing and supply chain expertise. As Vice President and Site Director of Avara’s Aiken, South Carolina, manufacturing facility, Patrick leverages his experience as both a contract provider and contract manager to deliver superior, client-focused service to Avara’s global clients.